NGM Biopharmaceuticals, Inc. is a clinical stage biotech company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to form a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine. To date, NGM Bio has generated a pipeline of seven drug candidates in various stages of development targeting liver, metabolic and ophthalmic diseases and cancer. The most advanced drug candidate, NGM282, is entering Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH). NGM’s strategic collaboration with Merck, which was extended to March 2022, will continue to provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
The QA contractor will support Quality Assurance and Quality Operations activities. The QA contractor will deliver timely review and resolution of quality matters related to CMO change controls, deviations, CAPAs and batch record review. The QA contractor will also support the creation, revision and archival of internal procedures and records, audit reports and CMO documentation.
Required Skills
- Review master and executed batch production records. Interface with internal stakeholders and CMOs to address quality matters in a timely manner.
- Prepare lot disposition documentation for approval.
- Review and approve controlled documents (e.g., SOPs, specifications, change controls, investigations, CAPAs, methods, protocols, reports) to ensure defined quality objectives are met.
- Review and approve method validation / transfer documents including protocols, reports, methods, change controls and specifications for biologics to support analytical operations across the clinical supply chain.
- Review and approve stability protocols and reports to support the stability programs for biologics across the supply chain.
- Interface with CMOs on deviations / investigations resolution and recommend implementation of appropriate CAPAs.
- Process internal document change requests and maintenance of the document control system.
- Perform other duties as assigned.
Required Experience
- Minimum 6 – 8 years QA experience in pharmaceutical or biotech, BS degree in science.
- Ability to recognize deviations from accepted practice and apply knowledge of cGMP.
- Prior experience working with CMOs.
- Prior experience with document change control, maintenance of the document change control.
- Strong knowledge of FDA guidelines and GMP regulations, industry practices and standards.
- Detail and quality-oriented with strong knowledge of quality assurance principles, systems and procedures.
- Ability to work effectively in a team-based environment.
- Ability to work independently in a fast-paced environment.
- Ability to multi-task, shift priorities under tight timelines and handle multiple projects simultaneously.