Manager, External QA
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 Manager is responsible for providing quality oversight for GMP activities at contract manufacturing organizations (CMOs), including batch record review, stability protocol / report review, analytical method validation / transfer / data review, deviation, change control and CAPA review and approval. The successful candidate must have a strong GMP background and be knowledgeable in biologics.
The individual will assist in the development and continual improvement of GMP quality systems at NGM Biopharmaceuticals in compliance with appropriate regulations, guidelines and procedures. The successful candidate must be able to work independently to support CMC activities in a fast-paced environment.
Job duties and responsibilities:
- Serve as project lead within the QA function. Manage QA activities related to review and approval of manufacturing, quality control (IPC, release, stability), environmental monitoring and analytical method validation records.
- Perform quality review of test results generated by the CMOs.
- Provide quality oversight of early phase GMP activities, manage outsourced CMO quality activities and collaborate with CMOs to address quality issues.
- Provide oversight of internal and external quality records, including investigation reports and CAPAs. Identify and implement appropriate corrective actions based on investigative findings.
- Participate in cross-functional project teams and serve as QA representative. Interface with internal and external stakeholders to address and resolve product and process related issues.
- Establish, maintain and report metrics to evaluate the Quality performance of CMOs.
- Assist in on Quality audits of NGM CMOs and suppliers.
- Manage the training program and provide GMP training.
- Revise SOPs and author new SOPs, as needed.
Experience and Education:
- Prior experience in disposition of clinical products and CMO Quality oversight.
- Strong biologics GMP and analytical background with an in depth knowledge of regulatory requirements for analytical method validation and transfer through development to commercialization.
- Ability to multi-task, shift priorities under tight timelines and handle multiple projects simultaneously.
- Strong knowledge of FDA guidelines and GMP regulations, QA principles, industry practices and standards.
- Knowledge of Quality Risk Management tools.
- Knowledge of Computer Systems Validation, including electronic records and signature requirements.
- Excellent written and verbal communication skills, detail-oriented with commitment to accuracy.
- 8 – 10+ years QA experience in the pharmaceutical / biological industry and a BS degree.
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.
Interested applicants should click "Apply"