Seeking a Sr. Manager, Quality Assurance with 7 years of experience in a pharma/biopharma company and 4+ years in a quality role. The Sr. Manager will be experienced in performing a wide variety of QA activities in support of internal GXP activities & for ensuring regulatory compliance, and provide leadership for maintaining and enhancing our quality and compliance culture. The candidate will report to the Director of GMP QA at our South San Francisco, CA location.
- Independently perform and/or manage batch release activities for clinical production, including but not limited to, review of batch records, analytical data, certificates of analysis, and other documents as needed for consistency with applicable regulations and for compliance with company’s GMP Quality System
- Provide direction for complex deviations, OOS investigations, and manage timely investigations and CAPAs in support of batch release
- Review and approve SOPs, Forms, Master Batch Records or other documentation related to manufacture, testing and release of clinical product
- Provide Quality support to the internal GMP manufacturing operations and facility
- Identify continual improvement opportunities
- Report quality issues and trends to management
- Represent Quality in cross-functional teams
- Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters are addressed in an open and timely manner
- Support and participate in Quality improvement initiatives
- B.S. or MS in Chemistry, Biology or related science
- 7 years of experience in the pharmaceutical / biopharmaceutical industry (4 years direct experience managing Quality).
- Ability to work effectively with various technical groups and a strong working knowledge in one or more of the following disciplines: API or drug product manufacturing, pharmaceutical sciences, analytical development / QC labs, GLP requirements.
- Proven management skills with ability to lead others effectively and experience to advocate a quality environment.
- Experience with Antibody Drug Conjugates a plus.
- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates good verbal, written, and interpersonal communication skills.
- Demonstrates proficiency in Microsoft Office applications.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
- U.S. citizen/green card holder required.