Senior Director: Bioanalytical Quality Control

Senior Director, Bioanalytical Quality Control - Contract - Philadelphia, PA

Proclinical is seeking a Senior Director of Quality Control to lead bioanalytical quality control operations for clinical and commercial cell therapy programs. This role focuses on managing quality control programs, including in-process and final drug product testing, and ensuring compliance with cGMPs and regulatory requirements.

Skills & Requirements:

• Bachelor's degree in biological sciences or equivalent; advanced degree preferred.
• Extensive experience in pharmaceutical quality control.
• Proven leadership in quality control laboratory management.
• Strong knowledge of biologics quality control.
• Ability to work effectively with multi-disciplinary teams.
• Detail-oriented with excellent analytical and communication skills.
• Capable of managing multiple priorities under tight deadlines.
• Experience with cell therapy products is advantageous.

The Bioanalytical Quality Control Senior Director will:

• Oversee daily GMP quality control testing for cell therapy products.
• Develop and lead the QC function, guiding facility expansion and product validations.
• Manage product lot release processes, ensuring timely completion.
• Coordinate bioanalytical programs and ensure compliance with timelines.
• Lead GMP investigations and corrective actions for laboratory issues.
• Support problem-solving efforts related to GMP quality control.
• Oversee product stability programs and data analysis.
• Facilitate technical transfer of new or revised methods with proper documentation.
• Ensure QC staff are trained and adhere to testing procedures.
• Initiate and approve quality control procedures and documentation.
• Participate in CMC regulatory submissions and health authority interactions.
• Lead QC interface during facility tours and inspections.
• Interpret and discuss laboratory data with cross-functional teams and authorities.
• Maintain high efficiency and accuracy in all operations.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.