Job Summary: Reporting to the Director of Quality Assurance, the Quality Assurance Manager is responsible for quality oversight of daily operational activities at contract manufacturing, packaging/labeling and testing facilities for products and services that support clinical studies (phase I through phase III) and products that meet commercial requirements. The position will provide quality guidance and work with MEI internal departments to ensure all applicable regulatory requirements and company quality management system requirements are met.
Role & Responsibilities:
- Primary QA contact with external vendors that manufacture, test, package, label, and/or distribute product or provide services for GMP activities. Responsible for quality approval of vendor generated documents – e.g., analytical methods, method validation protocols/reports, process validation protocols and reports, specifications, master batch/packaging records, label proofs, deviations, CAPA and change controls.
- Quality reviewer of executed batch/packaging records, product testing records (in-process, release, and stability), deviations, investigations, stability protocols/reports, method/process validation documentation, reference standard requalification documentation, certificates of analysis, certificates of compliance. Ensures all materials are manufactured in compliance with applicable regulations and MEI regulatory submissions.
- Dispositions drug substance\drug product batches and work-in-process materials for use in downstream manufacturing operations, dispositions final products for clinical or commercial use. Provides approval for shipment of product.
- Tracks and monitors internal open Deviations, Investigations and CAPA to closure in compliance with company procedures.
- Assigns appropriate expiration/retest dates on MEI investigational materials/products.
- Addresses shipping and storage temperature excursion notifications related to investigational products.
- Provides quality approval of new and revisions to existing MEI controlled documentation – e.g., SOPs, Forms, and Specifications.
- Receives, initiates and oversees investigation into product complaints for Investigational products.
- Provides guidance and support as a Quality representative on internal project teams.
- Tracks, evaluates and approves changes made to products, processes and GMP vendors.
- Collects, reviews and reports on Quality Metric data for Management Review purposes.
- Other QA activities may be performed as required.
Job Requirements and Education:
- Bachelor’s degree in a scientific/technical discipline with 10+ years’ pharmaceutical experience, or an equivalent combination of education and experience with expertise in the following:
- Operation within a virtual manufacturing environment.
- Current FDA, EMA, PMDA regulations and ICH guidances concerning the manufacture and testing of investigational and commercial products.
- Risk-based decision-making processes.
- Business, scientific, and personal computer hardware and software applications (MS Word, Excel, Access, Outlook, Adobe Acrobat) as well as with Electronic Data Management Systems. Experience with MasterControl desirable.
- High level of professionalism and collaboration in team settings. A willingness to adapt to changing situations.
- Experience in Drug substance or Drug product manufacturing desirable.
- Well-developed communication skills – written and verbal.
- Ability to work independently.
- Ability to manage tasks with competing priorities or deadlines.
- Successful experience in fast-paced entrepreneurial environment.
- This is an office-based San Diego position with a potential for travel as needed.
- Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
- Regular communication (hearing/speaking).
- Lifting 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.