Title: GMP QA, Sr. Manager / Associate Director
Location: Menlo Park, CA
Forty Seven Inc. is a clinical-stage biotech company that is developing the next generation of transformational immuno-oncology treatments.
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 guide and 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 10-15% domestic and international travel. The Sr. Manager / Associate Director of GMP QA will report to the Director, GMP QA.
These include, but are not limited to, the following; other duties may be assigned:
- Work directly with internal teams and CSPs to ensure that Forty Seven products (i.e., drug substance or drug product) meet 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 and lead GMP compliance audits (internal and CSPs).
- Develop and review Quality Agreements with CSPs and external parties, as needed.
- Provide quality assurance support for supplier qualification, technology transfer, scale-up, validation and other cGMP activities.
- Maintain quality systems processes and procedures: change control, compliance audit, quality investigations (i.e., deviations and OOS), supplier qualification and management, training, complaints, and CAPA; implement process improvements to ensure cGMP compliance.
- Support computer system validation activities to ensure cGMP compliance.
- Perform QA review and approval for GMP SOPs; author new procedures and revisions as needed.
- Review and approve Production Records, Specifications, Test Methods, Validation Protocols, Stability Protocols/Reports, 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 submissions.
- Represent the quality assurance department at project team meetings and provide quality guidance and leadership for internal teams.
- Assist with regulatory inspection readiness activities.
- Maintain close communication with GMP QA department, assist with other QA activities as assigned.
Education & Experience
- BA/BS degree in a scientific discipline. An advanced degree in a scientific discipline is a plus.
- 10+ years’ experience in GMP Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment; biologics experience a plus.
- Experience with contract service provider oversight and conducting audits.
- Experience with managing quality systems.
- Experience with preparation of CMC sections of US/EU regulatory submissions.
- Excellent verbal, written, interpersonal, and communication skills.
- Strong organizational and skills and able to work in a fast-paced and dynamic environment.
- Strong critical thinking and decision-making skills.
- In-depth knowledge of quality systems, cGMP, FDA/EMA regulations and ICH guidelines as applicable to product development and biologics manufacturing.