Associate Director, Quality Control
Associate Director, Quality Control
Apex Life Sciences has a permanent opening for Associate Director in Quality Control with Our Client, a leader in immunological innovation. Oversee activities associated with supporting the testing of phase 1-3 clinical stage products. Qualified applicants will have a strong technical background in development and manufacturing of viral vector drug substances and drug products, a proven track record managing relationships and influencing strategic outcomes with contract test labs and CMOs, and a deep knowledge of cGMP practices and requirements including supporting tech transfer qualification and validation, managing release and stability programs, data review and trending, supporting investigations, troubleshooting, equipment maintenance and calibration, and writing SOPs.
- Directs, develops, implements and maintains QC activities according to cGMP guidelines.
- Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and stability of company products.
- Designs and monitors Stability Programs, including data review and data trending.
- Establishes and maintains Product and Process retain program internally and externally reviews sampling plans to support characterization of the production process and release of company products.
- Creates concise documentation of all testing and communicate test results.
- Keeps updated with new FDA/EMA regulations and ICH guidelines.
- Assists with developing budget and monitoring expenditures.
- Makes recommendations for corrective action necessary to ensure conformity with quality specifications.
- Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations.
- Selects, trains and evaluates personnel to ensure the efficient operation of the function.
- Participates in the preparation of investigations, summaries and reports.
- Reviews data obtained for compliance to specifications and reports abnormalities.
- Revises and updates standard operating procedures as needed.
- Develops compliance strategy and generates and reviews method qualification and validation protocols and reports
- Maintains high level of professional expertise through familiarity with scientific literature.
- Fully complies with all company health and safety procedures and practices.
- Writing Standard Operating Procedures (SOP’s), test methods, and qualification/validation reports.
- Provides direct supervision to professional individual contributors and/or skilled, support individual contributors. Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems. Represents CMC group to support investigations.
Education and Experience:
- BA/BS degree in a scientific discipline with 10+ years’ experience; or equivalent combination of education and experience.
- Prefer 3+ years of management/leadership experience.
- Experience with troubleshooting, optimizing, transferring, and qualifying/validating analytical methods per US FDA and ICH guidelines.
- Experience in a cGMP environment with a track record of managing release and stability programs, successfully leading and supporting investigations, and troubleshooting.
- Demonstrated capability of interpreting and trending data and communicating and presenting results to peers and management.
- Demonstrated written and verbal communication skills with peers and management.
- Experience working with collaborative cross-functional teams at a fast pace in a dynamic environment and the ability to build and maintain positive and collaborative relationships across functional areas and with management.
- Expertise in protein, biological and analytical technologies (real time qPCR, ELISA, bioassays, multiplex PCR) and cGMP laboratory operations.
- Read and analyze complex scientific documents.
- Use fundamental mathematical and biostatistical concepts. Familiarity with computer systems, spreadsheets and macros.