Head of Quality Assurance
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.
Reporting to the President and COO, the Head of Quality Assurance will lead in the development, implementation and oversight of the company’s quality systems and ensure an appropriate level of effectiveness and compliance with GxP and other relevant ICH, US and EU regulations. The position will also be responsible for managing quality operations, training and infrastructure, in addition to performing internal and external audits. The candidate will provide strong leadership and expertise in setting and maintaining compliance standards, and will manage a team to ensure timely completion of goals and project deliverables.
- Assure high standards of Quality in all aspects of GMP, GCP and GLP compliance
- Foster a culture of continuous improvement in all aspects of GxP Quality, including the development and administration of policies and practices that address quality issues throughout the organization
- Develop and maintain GCP, GLP related quality system SOPs, and maintain GMP related quality system SOPs, in compliance with all applicable regulatory requirements and as appropriate for the company’s current needs
- Manage and mentor a team of quality professionals with varying degrees of experience
- Provide GxP QA oversight of external vendors’ quality programs, including negotiating and maintenance of quality agreements and vendor compliance
- Ensure our clinical trials, preclinical/nonclinical studies and manufacturing campaigns are performed in accordance with applicable protocols and in compliance with applicable regulatory requirements
- Evaluate quality events/incidents/issues and perform risk analysis, identify remediation actions and communicate to management or other stakeholders, as appropriate
- Manage/conduct external quality audits of clinical sites, clinical and preclinical vendors, CMOs and other manufacturing vendors
- Manage/conduct internal audits to ensure compliance with policies, procedures, GxP requirements and guidelines
- Design and oversee the administration the company’s training program
- Provide expert GxP advice to internal stakeholders
- Bachelor’s degree in a relevant scientific or technical discipline. An advanced degree and directly relevant professional certification are desirable.
- Minimum of fifteen years of experience in the pharmaceutical industry. At least ten years must have been at the senior management level with responsibility for manufacturing/GMP and/or GCP QA/QC. Management or supervisory experience leading a quality function is highly desirable.
- Strong knowledge of GCP, ICH, FDA, EMA, as well as other relevant US and international regulatory requirements. Broad understanding and experience in GxP and QA principles and industry standards are desirable.
- Experience with biologics development programs from early-stage to commercial is preferred.
- Ability to evaluate complex situations and to render judgments where significant legal, financial and regulatory risks exist and compliance guidelines are vague or not available.
- Strong organizational skills and the ability to participate effectively on cross-functional teams and across business unit lines.
- Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.
- Superb interpersonal, written communication and oral presentation skills.
- Travel will be required.
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.
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