Senior Director, Quality Control

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.

: 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.

Requirements

and regulatory standards and meet continuous clinical supply and delivery expectations leading to commercialization.

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.

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.

for human cells, including 21 CFR 210, 211, 820, and 1271; EudraLex; USP; EP; and ICH guidelines.

Qualifications

: Education/Training: Bachelor’s degree in biology, biochemistry, immunology, molecular and cellular biology, or a related scientific discipline required. 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.