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 commitement 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
We are currently seeking applicants for the following open positions. If your qualifications match the job requirements, please submit your resume for consideration to firstname.lastname@example.org.
Quality Assurance Document & Systems Manager
The Quality Assurance (QA) Document & Quality Systems Manager will be responsible for driving Quality initiatives, maintaining/improving quality infrastructure and participating as appropriate in various GXP activities, including Quality support for the oversight of manufacturing and testing of MEI products. The manager will also be responsible for administering MEI’s Document Control and Archival System. This includes participating in the development, roll-out, and maintenance of document control and records management procedures, tools, structure, and systems.
- Provide QA oversight and support to help guide MEI in its efforts to remain compliant to applicable regulations and its corporate policies and procedures.
- Provide support and assistance to MEI Management for identifying and also driving internal Quality initiatives and GXP improvement efforts.
- Manage and maintain corporate document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements.
- Manage the routing, review, approval, distribution and archival of new and revised controlled documents.
- Manage the periodic review program for controlled documents.
- Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports.
- Obtain, monitor, and report on document control metrics, and oversee document control compliance for the Quality department.
- Archive and maintain hardcopy and electronic copies of batch files, audit files, vendor files, product, label files and change history files.
- Provide guidance and training to employees on document control systems and document management procedures.
- Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures.
- Management of employee training files including tracking progress of employee training to ensure timely completion of assigned training.
- Define resource requirements, assign resources to task, and manage any assigned team.
Management Scope: None as this time
- Bachelor’s degree preferred degree in biological sciences, engineering, or chemistry
- Minimum of 5-7 years of experience in a pharmaceutical company. Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Proven ability and enthusiasm for developing and implementing new documentation systems in alignment with FDA’s Quality Systems Regulations (QSR), specifically document change management, training programs and complaint handling systems.
- Technical experience and knowledge in developing and coordinating documentation control systems compliant with FDA’s QSRs.
- Strong knowledge of SOPs, Quality Systems and of Document Control standards, practices, and principles.
- Works on multiple assignments in collaboration with various department system owners.
- Advanced Skills with MS Office applications Word, Excel, as well as Adobe Acrobat.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent writing and editing skills as well as interpersonal, verbal and written communication skills are essential in MEI’s collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Only San Diego candidates will be considered.
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.
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.