The Sr Director of Quality Control will be responsible for leadership of the various functional responsibilities of the Quality Control department, including QC - Operations, QC - Incoming Raw Materials, QC - Systems & Services, and QC - Microbiology Sterility Assurance. The role will lead continuous improvement activities of all quality control systems and drive a continued state of inspection readiness. The leader in this role must ensure that quality documentation and controls are effectively in place for phase III investigational new drugs (investigational medicinal products) to meet all quality requirements and regulatory standards and meet continuous clinical supply and delivery expectations leading to commercialization.
Essential Duties & Responsibilities:- Directs the development, validation, planning, implementation, and maintenance of QC product tests and analytical methods, processes, and operations.
- Supports the design and execution of the environmental monitoring and sterility assurance programs for GMP manufacturing operations.
- Supports development of QC tests and analytical methods that support production, including design support
- Validates analytical test methods for raw materials and finished goods
- Oversees raw material, in-process and final product release testing.
- Responsible for ensuring the appropriate stability programs are initiated and completed to support product development and customer requirements.
- Ensures quality control systems and equipment are compliant with standards and applicable regulatory guidelines
- Responsible for ensuring that project objectives are met & continuous improvement of the Analytical Laboratories.
- Strong scientific background and experience with cellular therapies across a broad range of cell types and disease treatments (adult-derived cells, stem cells, immune cells. allogeneic, autologous, etc.)
- Familiarity with applicable regulatory requirements and compendia concerning cGMP manufacturing and testing of human cells (21CFR210, 211, 820 and 1271; Eudralex, USP, EP and ICH).
- Understanding of analytical method qualification and validation per USP, EP and ICH guidelines.
- Responsible for developing and delivering training materials to ensure that all QC employees' operational, scientific, and analytical training is conducted as needed to ensure that the group is entirely and accurately trained on time for all QC activities.
- Responsible for liaison with the Manufacturing, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units.
- Provide support in resolving issues to meet project goals and deliverables.
- Serves as primary QC contact for regulatory inspections.
- Leads and participates in projects within the organization's objectives and project timelines and participates in cross-functional projects as the quality control subject matter expert.
- Hires, manages, and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff, including appropriate training, mentoring, and development of staff.
- Mentor's direct reports and guide them to the next level in their careers
- Is the primary point of contact and SME for analytical testing and provides guidance aligned with regulatory standards and good laboratory practices.
Qualifications:- Education/Training: Bachelor's degree in biology, biochemistry, immunology, molecular and cellular biology, or a related scientific discipline required. Advanced degree or Ph.D. in a scientific or technical discipline preferred.
- Experience: 10+ years of experience in a GMP-regulated biopharmaceutical environment, including 10+ years in a management or leadership role. Experience in biologics or cell therapy preferred.
- Knowledge: Strong knowledge of cGMP manufacturing and testing requirements for human cells, including 21 CFR 210, 211, 820, and 1271; EudraLex; USP; EP; and ICH guidelines. Understanding of analytical method qualification and validation per USP, EP, and ICH guidelines.
- Skills: Advanced root cause investigation, troubleshooting, laboratory data evaluation, risk management, project leadership, communication, relationship-building, and team leadership skills. Proficiency with Microsoft Word, PowerPoint, and Excel required.
- Certifications/Licenses: N/A
