A leading biotechnology company has an opening for a QA Manager, Gene Therapy!
General position summary:
The Quality Contractor will primarily manage the assigned programs focused on Gene Therapy modalities and possess a strong knowledge of cell-based production for drug development and transition to commercialization. This role is recognized to be knowledgeable in the principles and application of quality and regulatory compliance with significant knowledge of regulations applicable to Gene Therapy. The Quality Contractor adapts to new project requirements, business partnerships, effectively ensuring alignment with corporate goals and compliance with applicable regulations. This role is responsible for product disposition of clinical products which includes drug substance, drug product intermediate, and drug product. The Quality Contractor assists with the implementation of Quality System at contract manufacturers.
This position reports to the Associate Director, CMC Quality.
Key RESPONSIBILITIES: The responsibilities of this position may include, but are not limited to, the following:
1) Provide strategic GMP quality/compliance guidance to internal stakeholders as GMP QA trusted advisor on pharmaceutical development/CMC teams.
- Collaborative reviewer of procedures with external business partners and vendors
- Investigation guidance
- Understanding project plans, timelines and regulatory filing strategy and communicate them to Quality management in a timely manner
2) Disposition of externally produced materials and products in support of Clinical Studies which includes but not limited to –
- QA review of Executed Batch Records and resolution of comments/issues
- In-Process and Final product data review
- Reviews/Approves of Investigations/ OOS/ Change Controls to support Disposition. Also responsible for escalating the OOSs as necessary to MRB to support timely release of clinical supplies.
- Final Disposition documentation and updates in Oracle.
3) Product Transition to Commercial / Registration to Validation / PAI Readiness
- Evaluate CMO Quality Systems to ensure compliance with commercial expectations
- Mature the Quality Agreement(s) to commercial expectations
- Provide onsite support for registration batches
- Ensure source documents are approved and available
4) Collaborate with Partner on CMO Management and Performance oversight
- Establish and maintain Quality Agreement(s)
- Evaluate CMO performance to Quality Agreement(s) expectations
- Participate in Joint Development Committee and Face to Face meetings
5) Audit / Inspection Support
- SME Responder
- Preparation activities
- Provides both front & back room inspection support
- Support for Post inspection activities
6) Strategizing for Product Development in support of filing and approval of IND, IMPD, CTA
- Providing guidance in product and specification development
7) Change Controls- execution
- Owner /Assessor
- QA Approver : Resolve gaps; Approve change plans; Approve classification; Approve strategy for GMP release and disposition strategy
Master’s degree and 3- 4 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 8+ years of experience in Quality Operations and Manufacturing within the biotechnology industry, or relevant comparable background. Must have worked with external contract manufacturers of sterile and or biologics products.
Gene Therapy technical expertise along with a deep knowledge of GMP guidelines and Quality expectations for clinical phase programs. Comprehensive knowledge of domestic and international GMP regulations and subsequent applications to pharmaceutical drug development.
- Experience with pharmaceutical drug development process and transition to commercialization. Operational QA Experience preferred: Batch record review, data review, deviation review, change control experience, Oracle experience and Quality System background helpful.
- Demonstrate adaptability; think analytically with ability to conduct data analysis while paying attention to details
- Broad GxP Knowledge with ability to communicate effectively, collaborate and think critically to support impact assessments
- Ability to understand technical processes, Knowledge and application of risk management principles/ Risk Impact evaluation-aligning effort to level of risk
- Facilitation/ Problem Solving /organizational, planning, etc./ RCA tools/methodology/ Technical writing
- Working knowledge of GMP regulations and applicability to duties. Operational QA experience in analytical or manufacturing setting, interpretation and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc. Successful track record influencing cross functional teams
- Communication, Influencing, Relationship Management/conflict mgmt.
- Questioning-Ability to understand and translate customer needs
- In depth knowledge of GMP/GDP regulations and application
- Strong Quality Systems experience/background, experience presenting to cross functional audience, Coordination and planning experience-
- Critical, analytical and Strategic thinking
- Ability to assess impact across multiple procedures and systems
- Cross functional collaboration, in-depth GMP knowledge, and experience in Presentation/Facilitation/ Risk Mgmt
- Previous CMO oversight experience:
- Broad GMP knowledge across lifecycle of the product
- Ability to Negotiate and Collaborate with team members to achieve results