Careers

MEI Pharma's staff is a team of friendly, dedicated, experienced and collaborative professionals committed to the hard work that supports our company's aggressive goals and to the workplace values that promote our success.

Our workplace values include:

  • Shared commitment to excellence and collaboration across functions
  • Personal accountability for consistent superior performance
  • Fiscal discipline applied wisely in the use of resources
  • Mutual trust and respect for individual differences
  • Dedication to developing novel therapies for our patients

 

 

 

Open Positions

Clinical Research Associate

Job Summary: The Clinical Research Associt3e (CRA) or Senior CRA (SCRA) role is to assist the Senior Manager, Clinical Operations during the conduct of one or more clinical studies. The CRA/SCRA assures successful conduct of MEI-sponsored clinical studies consistent with applicable regulations, guidelines, and procedures.

Role and Responsibilities:

  • Assists the Senior Manager Clinical Operations in overseeing clinical studies to ensure compliance with the study protocol, timelines and budgets
  • Supports investigational site startup activities, including the creation and review of study-related documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions, and Essential document packages
  • Supports the development and design of CRFs and IWRS systems, including participation in UAT.
  • Assists with the set-up of central labs and imaging vendors
  • Supports site training and engagement activities
  • Reviews relevant systems to track subject screening, enrollment, and study visits,
  • Reviews monitoring visits reports, tracks resolution of action items, and identifies and supports resolution of any site performance issues
  • Reviews clinical data on an ongoing basis to identify/resolve data issues and tracks the query process to identify/report evolving trends in the data
  • Participates in project team meetings and conference calls to review progress of ongoing clinical trials
  • May conduct co-monitoring visits to oversee CRO personnel and study conduct at the site

Qualifications:

  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with minimal oversight.
  • Demonstrates professionalism and presents a positive image of the company.
  • Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
  • Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
  • Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
  • Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
  • Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.

Job Requirements and Education:

  • Minimum 3 years’ experience as a CRA in the biotechnology or pharmaceutical industry; experience in hematology and/or oncology preferred
  • BS degree in a science or health-related science discipline or equivalent preferred
  • Proficient knowledge of GCP and ICH and medical terminology
  • Ability to prioritize and multitask to ensure tasks are completed on or ahead of time
  • Strong interpersonal and communication skills
  • Excellent team, organizational, and planning skills
  • Highly competent in Microsoft Office Suite including MS Word, Excel, PowerPoint

Employment type

Full time 

ADA Notations:

  • This job operates in a professional office environment, using standard office equipment
  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Routine office duties including computer keyboard use and some lifting of light-weight office equipment, supplies and files as needed
  • Vision requirements include: close vision and ability to focus
  • Noise conditions range from quiet to moderate

 

Apply Here

Director Clinical Scientist

Job Summary:

The Director, Clinical Science, participates in the development of the Clinical Development Plans (CDPs) and supports the assigned Medical Director and VP of Clinical Development with various deliverables necessary for effective and efficient CDP development and execution for the assigned asset(s) and/or indication(s).

The Director of Clinical Science is expected to perform his/her responsibilities with independence and is likely to have external interactions with key opinion leaders (KOLs), cooperative groups, and external vendors supporting the work of Clinical Science.

Responsibilities & Duties:

  1. Global Clinical Development Planning
  • Gathers information from and collaborates with a variety of external stakeholders, such as clinical investigators, clinicians, scientists, and KOLs, and ith multidisciplinary internal groups, for the development of CDPs
  • Supports Medical Directors in developing and/or preparing clinical science information for inclusion into the strategy for the relevant therapeutic/disease area(s), annual and strategic lifecycle plans, and the integrated commercialization plan
  • Maintains scientific and clinical knowledge in the relevant therapeutic and disease area(s)
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of clinical science to maintain a fully current view and perspective of internal/external influences and/or implications for the relevant therapeutic and disease area(s)
  1. Clinical Development Plan Implementation
  • Provides clinical science support for assigned studies and programs
  • Conducts appropriate literature searches
  • Provides input on clinical study design
  • Designs clinical protocols, manuals and forms with guidance and oversight from Medical Directors
  • Collaborates with clinical operation for the successful implementation of clinical trials, including Informed Consent Form (ICF), protocol eligibility checklist, protocol dose modification plans, Case Report Forms (CRFs), CRF instructions
  • Writes and/or reviews additional clinical science documentation and/or clinical science input into other documentation managed by other groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
  • May develop or provide input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with Medical Directors (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
  • Provides additional support with site training, as needed, or requested
  • Support Clinical Development team in clinical review of study data
  • Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments
  • Supports Medical Directors/ Physicians in preparing for internal/external meetings and presentations
  • Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  • Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
  • Coordinates submissions to scientific meetings and/or other appropriate venues or groups
  • If directed, supports Medical Directors, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation
  • Completes and/or leads other special projects, as and when assigned, or otherwise requested
  • Consistently complies with all governing laws, regulations, Company’s Standard Operating Procedures (SOPs) and other guidelines
  • Represents Clinical Development in operational meetings and data management meeting, as needed

Minimum Requirements

  • Advanced Clinical/Science Degree is preferred (e.g., PhD, PharmD, MD)
  • 10 or more years clinical trial experience (must demonstrate a minimum of 5 years clinical trial experience in pharma/biotech industry) with relevant therapeutic area experience
  • Clinical and/or basic science research in oncology, with hematologic malignancies preferred
  • Experience authoring experimental protocols and/or study results and conclusions
  • In-depth understanding of Phase 1 through 4 drug development
  • Strong analytical skills, especially understanding and interpreting scientific research and literature
  • Experience in the principles and techniques of data analysis, interpretation and clinical relevance
  • Comprehensive understanding of product and safety profiles
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
  • Good business acumen; has working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment
  • Good interpersonal, verbal communication and influencing skills; can influence without authority
  • Strong written communication skills
  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
  • Ability to travel (~20%)

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs.
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Director/Sr. Director of Safety and Pharmacovigilance

Job Summary: 

Responsible for establishing and implementing the safety and pharmacovigilance function at MEI Pharma, including the development of policies, processes, and action plans.  Oversee drug safety/pharmacovigilance vendor(s) and CRO(s), ensuring safety functions and deliverables are of high quality in accordance with the world-wide regulatory requirements, master service agreement, quality agreement and applicable statement of work. This position will lead the development and maintenance of pharmacovigilance/safety related plans with corporate partners and CROs including safety management plans, and regulatory reporting plans.

 

This position will coordinate activities between internal MEI Pharma groups and safety/PV vendors for company-sponsored trials and investigator-initiated trials; support the planning and reviewing safety reports; and provide guidance and support to project development teams for safety-related areas including protocol development, updates to investigators brochures, informed consent forms and study conduct as required.

This position is expected to oversee safety and pharmacovigilance direct reports.

Role & Responsibilities:

  • Responsible for the development, implementation and maintenance of policies, processes and procedures to ensure compliance with FDA and international regulations and guidance.
  • Apply safety concepts (FDA, ICH, other international guidelines) to daily functions.
  • Responsible for the operational aspects of MEI Pharma Safety Department.
  • Service as the main point for drug safety evaluation and pharmacovigilance activities.
  • Develop safety training to company employees, contractors and service providers, as applicable.
  • Ensure all reporting is completed within the required timeframes.
  • Perform other safety/PV operations-related tasks as necessary.
  • Responsible for project timelines and management of reporting to FDA as needed.
  • Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations.
  • Participates with all disciplines within the organization to obtain and/or provide information for AE and PV related filings.

Qualifications:

  • Excellent written and verbal communication skills.
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Safety Management department activities.
  • Excellent organization skills, time management skills, and ability to handle multiple priorities while adhering to applicable timelines.
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with minimal oversight.
  • Strong knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
  • Demonstrates professionalism and presents a positive image of the company.
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
  • Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
  • Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect.

Job Requirements and Education

  • A minimum of 10 years of experience in Drug safety and Pharmacovigilance in the industry (biopharma and/or CRO) with at least 3 years at a management level
  • Graduate degree, such as RhP, PharmD, MD, PhD, MSN, or equivalent
  • Prior experience with mentoring/training of staff
  • Demonstrated competency within a Safety Databases,
  • Computer literacy and experience working with Microsoft Office (Word, Excel) required

ADA Notations:

  • This job operates in a professional office environment, using standard office equipment.
  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Routine office duties including computer keyboard use and some lifting of light-weight office equipment, supplies and files as needed.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.
Apply Here

Medical Science Liaison - Southern or Western US

Job Summary

Reporting to the Director of Medical Affairs, the Medical Science Liaison (MSL) is a field-based position that develops and enhances professional relationships with medical thought leaders, investigators and key medical organizations involved in cancer drugs development.  The MSL provides medical information through medical and scientific discussions and communications in a balanced, non-promotional manner.  The role is performed in accordance with all applicable legal, regulatory and professional guidelines.  This is a challenging position in a fast-paced setting that requires a highly-motivated, self-starter. 

Responsibilities

  • The MSL ensures the appropriate dissemination of clinical and scientific information regarding MEI’s oncology pipeline compounds in a timely and customer-focused manner to all appropriate parties.
  • Identifies specific Key Opinion Leaders in the oncology field and establishes and maintains scientific relationships with them in their academic and community cancer centers around the country.
  • Provides clinical communication through presentations and information in response to questions from the academic and healthcare-provider settings.
  • Collaborates with the in-house Clinical Operations Department to enhance patient enrollment in company-sponsored clinical trials by identifying appropriate clinical trial sites and interacting with investigators in ongoing studies.
  • Provides scientific and medical information updates and scientific support at medical meetings.
  • Provides timely feedback and information on emerging clinical and scientific teams as well as opportunities to internal staff.
  • Furnishes scientific support for appropriate educational initiatives.
  • Ensures all activities are compliant with MEI’s company policies.

Requirements:

  • Advanced scientific degree (MD, PhD, PharmD) with at least 5 years of relevant industry experience.  Hematology/Oncology MSL experience is strongly preferred along with a solid professional reputation for interacting productively with thought leaders in the field.
  • Thorough comprehension of the oncology drug development process is required.
  • Demonstrated ability and experience to effectively present clinical/scientific information to a variety of audiences is essential.
  • Respectful, accountable and collaborative abilities to work with in-house teams and all outside collaborators.
  • Able to spend a significant amount of time in the field directly interacting with thought leaders, investigators and hematology/oncology professionals.
  • Superior time management skills to balance multiple priorities and to meet deadlines.
  • Ability to create materials such as reports and presentations for inside and outside the organization.
  • Approximately 50-60% travel is required; overnight travel required as needed.
  • Must possess a valid driver’s license and a good driving record.
Apply Here

Paralegal/Patent & Contracts Administrator

Job Summary:  The Paralegal/ Patent & Contracts Administrator reports to Associate General Counsel.  This person will work closely with the legal department personnel, along with all departments to administer the company’s patent estate as well as negotiate and draft contracts with various third parties including venders and clinical trial sites. This position requires experience negotiating and drafting contracts typically entered into by a life science company as well as clerical and analytical skills to support both patent and contracts functions.

Role & Responsibilities:

  • Provide support to the patent function that includes managing and maintaining patent docket and patent portfolio. Primary interface for outside patent counsel.  The patent responsibilities for this position are administrative.  The company’s General Counsel and outside patent counsel are responsible for patent strategy and prosecution
  • Draft, review and negotiate contracts, including CDAs, MSAs, consulting agreements, clinical trial agreements and other clinical documents
  • Assist the legal group in various tasks related to the management of patent and contracts
  • Assist in the management of public disclosures and publications as it relates to IP rights
  • Other duties as directed by the legal group

Qualifications:

  • Must have experience with CTAs, ICFs and LOAs, as well as a variety of other types of contracts
  • Must have knowledge of patent and contracts terminology
  • Strong knowledge of the clinical research process
  • Excellent written and verbal communication skills
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute department activities
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with minimal oversight
  • Excellent time management skills
  • Demonstrates professionalism and presents a positive image of the company
  • Prioritizes time effectively based on project needs. Consistently meets deadlines
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties
  • Demonstrates honesty and integrity in dealing with others, works effectively with different types of people and accepts constructive feedback without becoming defensive
  • Seeks input from others when faced with a difficult situation, makes sound decisions within the scope of responsibility and focuses on resolving problems rather than placing blame
  • Establishes and maintains effective relationships with clients (internal and external) and gains their trust and respect, provides clients with complete and accurate information, and acts with the client in mind

Job Requirements and Education

  • Bachelor’s degree or associates with 5 years in the pharmaceutical or biotech industry
  • Experience in MS Office product (Excel, PowerPoint & Word) and Adobe
  • Self-directed nature, ability to work independently with minimal supervision, and ability to follow directions, is detail-oriented and can multi-task
  • Self-motivated and able to organize and prioritize multiple tasks
  • Excellent interpersonal, verbal and written communication skill

Employment type

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Senior Director, Clinical Quality

Job Summary:

This position requires a strong leader as part of the Quality team to lead MEI Pharma’s Clinical QA function. The Sr. Director of Clinical Quality will serve as a strategic and tactical quality professional in managing compliance related to Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), Good Pharmacovigilance Practices (GPVP’s) and other related activities. Responsible for ensuring oversight of compliance with GCP, GLP, and GPVP global regulations, industry best practices, and internal policies and procedures, including designing and implementing a risk based GCP audit program. Partner with the Clinical Development and Clinical Operations organizations to provide strategic GCP, GLP, and GPVP compliance oversight for clinical studies and internal operations and drive a robust risk-based vendor management program.

Management Scope:  May require management of FTEs.

Responsibilities & Duties:

  • Lead MEI Pharma’s Clinical QA function while promoting a culture of quality by collaborating across all departments and levels of management to accomplish company objectives and represent Quality.
  • Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
  • Directly interface with Clinical Development and Clinical Operations for GCP audits of internal processes. Promote collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
  • Partner externally to perform effective audits of vendors (CROs), investigator/clinical sites, and ensure documents are tracked and maintained within standards (e.g. Trial Master Files, Clinical Study Reports, Protocols, etc.).
  • Work with Clinical Operations and Regulatory Affairs to review IND and NDA submissions to ensure data and documents meet GCP guidelines.
  • Perform GCP training of internal company employees.
  • Planning, coordination, control, and continuous improvement of processes and systems to assure the quality of clinical studies. Provide input and change management for quality improvements affecting CQA processes.
  • Create, maintain, and revise CQA SOPs and documents that support the Quality Management System.
  • Development and implementation of GCP-related Quality Management System processes. Oversee audit plans and activities actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance.
  • Lead the GCP, GLP, and GPVP inspection management program, including inspection readiness activities, inspection conduct, and preparation of responses to health authorities.
  • Assess new and emerging regulations and applies in a fit for purpose manner to MEI’s Quality Management System and practices.
  • This position requires travel up to 25%.
  • Other duties as assigned.

Minimum Requirements

The position requires a BS or BA degree or equivalent in a science or health care field and significant experience in an FDA-regulated environment. Minimum of 15 years of experience in the pharmaceutical industry with a GCP focus, ideally covering all clinical phases through commercial drug product, with at least 5 years in a GCP quality/compliance role. Broad knowledge of clinical processes and procedures, electronic documentation systems, and GCP, GLP and GPVP regulations and guidance with demonstrated effectiveness in maintaining CQA control processes for compliance with regulations. Experience conducting quality audits of CROs and Investigational sites. Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. Demonstrates initiative and proactively provides collaborative support to the clinical team as a credible communicator. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction to follow through with specific tasks. Continuously demonstrates a positive, ‘can do’ and service-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy. Ability to plan and organize work in an efficient manner, multi-task and shift priorities quickly while working under time constraints. Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development. Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Lifting up to 25 lbs.
  • Routine office duties including computer keyboard use
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.
Apply Here

Senior Director, Marketing – New Products

Job Summary:

The role will be responsible for building and managing the New Product Planning Team for MEI Pharma Inc. (MEI). This role will be accountable for providing cross functional strategic commercial insights that will inform product development team decisions for all pipeline assets.

On an ongoing basis the position will be responsible for establishing partnerships with R&D and Clinical in designing pre-clinical, clinical, lifecycle studies and trials to ensure differentiation-impacting decisions are driven commercially to ensure development of innovative, differentiated products that meet unmet needs.

Role & Responsibilities:

  • Lead initiatives to continually assess the commercial values, competitive landscapes and market differentiations (incorporating KOL advice) of the early assets and develop and communicate commercial priorities for resource allocation and decision making.
  • Lead and execute market research, analytics and forecasting as needed to inform strategic plans, tactics and executive level decision making.
  • Develop strategic and tactical plans that describe the progression of activities including TPP development, early positioning, segmentation, KOL identification and mapping, medical communication & education, INNs and brand naming etc.  Execute on planned activities as development timing requires.
  • Develop and own relationship with relevant KOLs.
  • Develop and manage annual budgets, long range plans and determining the best allocation of global resources for the pipeline.  
  • Work with legal, regulatory, medical affairs, corporate communications, clinical development, and translational medicine to ensure global alignment of the proposed commercial strategy.
  • Work with Market Access, Patient Advocacy, Medical and HEOR to develop differentiation strategies and compelling value proposition to secure appropriate market access.
  • Accountable for directing competitive intelligence.
  • Support Business Development in identifying and evaluating potential in-licensing, out-licensing and partnership opportunities. 

Qualifications:

  • Bachelor’s degree in life sciences or Marketing required, MBA preferred
  • Excellent verbal and written communications skills are necessary as well as attention to detail and technical aptitude
  • Executive director level requires at least 15 years of pharmaceutical experience with at least 10 years in pharmaceutical Marketing, 3 of which should be in New Product Marketing
  • US and Global biopharmaceutical marketing experience required
  • Previous product/indication launch experience required
  • Oncology experience required
  • Demonstrated track record of commercial success in positions with progressive responsibilities

ADA Notations:

  • This job operates in a professional office environment, using standard office equipment 
  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Routine office duties including computer keyboard use and some lifting of light-weight office equipment, supplies and files as needed
  • Vision requirements include: close vision and ability to focus
  • Noise conditions range from quiet to moderate
Apply Here

Sr. Director/Director GMP Quality Compliance

Job Summary:  The Director, GMP Quality Compliance position requires a strong leader as part of the Quality team to lead MEI Pharma’s GMP Quality Compliance function. The Director of GMP Quality Compliance will serve as a strategic and tactical quality professional in managing GMP compliance related to contract organizations and internal processes encompassing Good Distribution Practices (GDP’s) and Good Manufacturing Practices (GMP’s). This position plays a significant role in support of the vendor management program and other related activities including, but not limited to, inspection readiness, inspection management, internal audit, external audit, and due diligence. The Director of GMP Quality Compliance is responsible for ensuring oversight of compliance with FDA, EMA, PMDA, regulations and ICH guidelines applicable to GDP and GMPs, industry best practices, and internal policies and procedures. The Director of GMP Quality Compliance will be responsible for surveillance of industry trends and changing regulations and will provide ownership and oversight of continuous improvement of GMP compliance processes. The position will partner with the Manufacturing, Supply Chain, and Pharmaceutical Sciences organizations to provide strategic GDP and GMP compliance oversight for all MEI Pharma programs and internal operations.

Management Scope:  May require management of FTEs.

Role & Responsibilities:

  • Lead MEI Pharma’s GMP Compliance function while promoting a culture of quality by collaborating across all departments and levels of management to accomplish company objectives.
  • Lead the GMP inspection management program, including pre-approval inspection readiness of vendors and suppliers, internal inspection readiness activities, inspection conduct, and preparation of responses to health authorities.
  • Lead the GMP external audit program including development, maintenance and execution of the annual GMP audit plan. Partner externally to perform effective audits of GMP vendors (contract manufacturing (CMO), laboratory (CTL), distribution (3PL), and computer service organizations), and ensure responses are tracked and effectively completed.
  • Lead the GMP internal audit program and collaborate internally to execute routine, risk based monitoring and auditing of relevant internal GMP business activities to applicable regulations, guidelines, policies and procedures; identify potential areas of compliance vulnerability and risk; oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the business.
  • Ensure all audit observations are communicated, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements.
  • Facilitate the MEI Pharma field alert, recall, or product withdrawal processes and associated committees.
  • Perform GMP training of internal company employees.
  • Drive continuous improvement efforts and support the development and implementation of the Quality Plan to ensure MEI Pharma quality objectives are met.
  • Assess new and emerging regulations and inspection trends for impact to GMP activities and apply changes in a fit for purpose manner to MEI’s Quality Management System and practices.
  • As required, provide performance reviews, development plans and set goals for department staff in alignment with company goals.
  • This position requires travel up to 25%.
  • Other duties as assigned.

Qualifications:

  • Demonstrates initiative and proactively provides collaborative support to the operational teams as a credible communicator.
  • Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction to follow through with specific tasks. Continuously demonstrates a positive, ‘can do’ and service-oriented attitude.
  • Strong oral and written communicator; detail-oriented with a commitment to accuracy. Ability to plan and organize work in an efficient manner, multi-task and shift priorities quickly while working under time constraints.
  • Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Job Requirements and Education

  • BS or BA degree or equivalent in a science or health care field and significant experience in an FDA-regulated environment.
  • Minimum of 12 years of experience in the pharmaceutical industry with a GMP focus, ideally covering several areas supporting commercial manufacturing operations, with five (5) years in a GMP quality role.
  • Demonstrated competence in direct participation in health authority inspections is required. Broad knowledge of GMP processes and procedures, electronic systems that support manufacturing operations, and GDP and GMP regulations and guidance with demonstrated effectiveness in maintaining audit programs.
  • Experience conducting quality audits of CMO, CTL, 3PLs, and computer system providers.
  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.

Employment type

Full time 

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Lifting up to 25 lbs.
  • Routine office duties including computer keyboard use.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.

 

Apply Here
Equal Opportunity Employer:

MEI Pharma, Inc.'s policy is to provide equal opportunities to all employees and employment applicants without regard to unlawful considerations of race, color, national ancestry, sex, gender, age, religion, physical or mental disability, medical condition, genetic information, pregnancy, marital status, sexual orientation, gender identity, gender expression, military or veteran status or any other classification protected by applicable local, state or federal laws.

Recruiters, Agencies:

The recruitment and employment process at MEI Pharma, Inc. is managed exclusively through the Human Resources Department with all candidates applying directly in this manner. The company does not accept unsolicited resumes from any source other than from qualified candidates and only for current open positions.