GMP / Quality Lead
Trenton Metro Area, NJ
Provide leadership for continuous improvement in all aspects of GMP Quality. This includes the development and administration of policies and practices which address quality issues throughout the organization.
- Direct and conduct GMP based Quality audits, and associated CAPA.
- Ensure vendor oversight as well as inspection readiness.
- Serves as representative in manufacturing based audits with the FDA and other government agencies.
- Provide guidance and direction regarding manufacturing Quality to project teams. This includes, but is not limited to, documentation, training, change control, investigations, deviations and record review.
- Provide expert knowledge regarding data integrity program including computer system validation practices, as appropriate.
- Develop and execute training programs regarding cGMP, quality management techniques, etc.
- Act as subject matter expert regarding SOPs for GMP Quality functions
- Education and Experience
- Bachelor s degree in a scientific/technical discipline.
- Advanced degree in biotechnology, microbiology, biochemistry preferred.
- Minimum of 10 years of directly relevant pharmaceutical industry experience
- At least 5 years working with biopharmaceuticals, preferably monoclonal antibodies.
- Subject Matter Expert on current standards for quality assurance of sterile biologic medicinal products including: aseptic processing, sterility assurance, equipment and process validation, quality control, environmental monitoring, and facility management.
- Strong knowledge of cGMPs as well as other relevant regulatory requirements and experience in interacting with the Health Authorities in GMP inspections