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Job type: Contract

Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)

Location: United States

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.

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