Company:  Confidential

Job Title: Associate Director, Quality Control

Job Number: 34310

Location: 10865 Road To The Cure San Diego, CA 92121

Job Description

The Associate Director, QC is accountable for managing the activities of Quality Control personnel across all sites. The Associate Director, Quality Control responsibilities include developing and coaching technical staff, prioritizing and workforce planning for routine production support, implementation of technical projects, and process optimizations. The position requires strong technical knowledge of ICH, cGMPs and analytical methods, applicable global regulatory manufacturing guidance, and the corporate/industry standards for qualification and validation. The position requires working cross-functionally across all sites, program teams, and other functions to successfully deliver corporate goals, production plans and quality objectives.

Responsibilities

– Ensure a deep understanding and application of International Council for Harmonisation (ICH) guidelines, current Good Manufacturing Practices (cGMPs), and analytical methods in all quality control processes
– Lead the development, implementation, and maintenance of robust quality control systems, ensuring alignment with corporate and industry standards for qualification and validation
– Oversee the development and validation of analytical methods, ensuring accuracy, precision, and reliability in the evaluation of cell therapy products

Required Skills

– Requires a Ph.D. in Chemistry, Pharmaceutical Sciences, or related field with 10+ years experience in Cell and Gene Therapy and 5+ years of experience in development of sterile, injectable dosage forms.
– 5+ of experience in Quality Control in a pharmaceutical manufacturing environment.
– Strong technical knowledge and experience in method development, qualification and validation.
– Knowledgeable of Quality by Design concept and execution is required
– Experience with IND and BLA submission is highly desirable
– Experience with inspection readiness, regulatory inspections and commercial manufacturing is highly desirable

 

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