We are partnered with an outstanding client who are looking to bring in an Assistant Vice President of Quality Control. They work in Gene therapies specifically AAV and LV based therapeutics. They are located in New Jersey and are looking to have you start soon!
Responsibilities:
- Overall responsibility for leading the strategic planning and technical operations of the Quality Control Department to ensure that business needs are met.
- Work with complex issues that require broad-based sustainable solutions involving other functions.
- Represent QC on the cross-functional meetings for AAV and LVV Platforms to ensure that common company objectives are met.
- Partner and align with Analytical Development/CMC/Pharmaceutical Development and Program Management to implement strategies and drive organizational success.
- Plan strategically/proactively with management to ensure that resources are allocated adequately to meet each program’s needs.
- Oversee critical investigations (e.g., failure/CAPA) to ensure that these result in thorough root cause analysis & implementation of effective preventive actions.
- Ensure method validations & transfers meet regulatory expectations & requirements.
- Ensure accuracy & scientific soundness of QC laboratory data.
- Ensure GMP compliance with laboratory operations and contribute to the compliance of site.
- Identify and monitor key performance metrics to optimize quality and productivity of the laboratory.
- Ensures quality control systems and equipment are compliant with all applicable regulatory guidelines and data integrity principles are adhered to, to provide confidence in the data generated.
- Tracks and trends cGMP data including the evaluation and approval of data received from external contract laboratories. Compiles and reports data with appropriate interpretations for applicable management reviews, Annual Product Reviews, and all other required assessments.
- Ensures continuous improvement across the Quality Control department.
- Maintain awareness of competitors, markets, best practices, and new industry standards and development
Experience:
- PhD. in Molecular Biology, Cell Biology, Immunology, or related field with 15 years of experience in GMP/QC environment or equivalent experience in the biotechnology industry; M.S. with 15 years of experience GMP/QC environment or BS with 18 years of experience GMP/QC environment.
- Minimum of ten (10) years of leadership experience required.
- Experience with Gene/Cell therapy products (CART-Therapies) for clinical and commercial.
