Associate Director of Quality Control
About The Position
The Associate Director, Analytical Quality Control provides strategic and operational leadership for the analytical quality control organization supporting GMP manufacturing, product release, stability testing, and analytical method lifecycle management. The role oversees QC analytical laboratories and ensures testing activities comply with cGMP regulations, regulatory expectations, and company quality standards. The position leads and develops QC professionals, oversees analytical testing and quality systems, monitors performance and product quality, and coordinates with internal departments and external companies to support technology transfer and effective laboratory operations. It also works with Quality Assurance to maintain an effective quality management system and is responsible for a GMP-compliant analytical laboratory and safe working environment.
Requirements
- MS or BS in Analytical Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline.
- 10+ years of experience in biopharmaceutical analytical testing within GMP environments.
- 5+ years of leadership experience.
- Experience supporting clinical and commercial manufacturing programs.
- Strong knowledge of regulatory requirements and standards governing biopharmaceutical quality control, including cGMP, ICH, FDA, and EMA requirements.
Responsibilities
- Ensure QC systems and practices are developed and implemented in accordance with GMP requirements.
- Lead, mentor, and develop a team of quality control professionals, fostering excellence, collaboration, and continuous improvement.
- Manage analytical method development, phase-appropriate method qualification and validation, and release and stability testing.
- Ensure testing data is accurate and delivered on time.
- Provide mentorship to direct reports and communicate clearly about their performance.
- Maintain proficiency in quality systems, including SOPs, protocols and reports, release and stability data review, OOT and OOS management, Good Documentation Practices, LIMS and cGMP data traceability, deviations, and change management.
- Own QC metrics to assess overall and individual performance and identify and apply continuous improvement opportunities.
- Manage QC inputs to Annual Product Quality Reviews and Quality Management Reviews.
- Oversee trending of commercial product quality for Drug Substance, Drug Product, and Finished Product, as well as commercial QC analytical method performance.
- Manage QC deviations, CAPAs, and change controls for clinical and commercial products.
- Collaborate with Manufacturing, MSAT, AD, and Validation to support effective technology transfer from internal departments and external companies.
- Oversee the management team to build subject matter expertise and support scientists’ motivation, education, efficiency, and individual performance management.
- Coordinate with Analytical Development resources to optimize test methods and execution, streamline laboratory functions and operations, and improve their quality.
- Oversee and support method validation and verification activities and method transfer between sites for clinical and commercial products.
- Work with the Quality Assurance Department to improve and sustain an effective and efficient quality management system.
- Ensure a GMP-compliant analytical laboratory and safe working environment.
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What This Job Offers
Job Type
Full-time
Career Level
Director
