Title: Manager / Associate Director, GMP QA
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.
This position is responsible for providing quality oversight and managing the quality aspects of clinical drug substance/drug product manufacturing at contract services providers (CSP). This position will also support the development and management of Forty Seven’s internal quality systems. The candidate should have strong technical, communication and interpersonal skills. The position requires 5-10% travel. The Manager / Associate Director of GMP QA will report to the Director, GMP QA.
These may include, but are not limited to, the following; other duties may be assigned:
- Work directly with operating entities (internal and CSPs) to ensure that Forty Seven products (i.e., drug substance or drug product) meet all required quality standards and specifications.
- Review manufacturing and labeling batch records and perform lot disposition activities in collaboration with CMC department to ensure ongoing clinical drug supply.
- Plan, schedule and perform QA audits (internal and CSPs) to verify cGMP compliance.
- Provide quality assurance support for supplier qualification, quality agreements, technology transfer, scale-up, validation and other cGMP activities.
- Maintain quality systems processes and procedures such as change control, compliance audit, quality investigations (i.e., deviations and OOS), supplier qualification, training, CSP management, complaints, and CAPA resolutions, and implement process improvements as needed to ensure cGMP compliance.
- Author new SOPs and revisions as needed for process improvements and compliance.
- Review and approve Production Records, Specifications, Test Methods, Validation Protocols, Stability Protocols/Reports, SOPs and other cGMP documentation as assigned.
- Facilitate resolution of quality issues with internal and external parties in a timely manner. Coordinate communications with CSPs and internal team for quality issues.
- Perform QA review of CMC sections of regulatory filings.
- Represent the quality assurance department at project team meetings.
- Maintain close communication with QA management, assist with other QA activities as assigned.
Education & Experience:
- BA or BS degree in a scientific discipline. An advanced degree in a scientific discipline is a plus.
- 5+ years’ experience in Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment; biologics experience a plus.
- Experience working with contract service providers
- Experience with managing quality systems; audit experience preferred
- Experience with preparation of CMC sections of US/EU regulatory submissions is desirable.
- Must have excellent verbal, written, interpersonal, and communication skills
- Exemplary organizational and time management skills, and able to work in a fast-paced and dynamic environment.
- Strong working knowledge of cGMP, FDA/EMA regulations and ICH guidelines
- Position may require occasional evening and/or weekend commitment
- Position may require working with biological and/or chemical hazards
- Position may require occasional travel (~25%), domestic and international.