Director, Quality Assurance
NGM Biopharmaceuticals, Inc. is a private 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 six drug candidates in various stages of development, including NGM282 that recently demonstrated proof-of-concept in a Phase 2 study in non-alcoholic steatohepatitis (NASH). In 2015, we entered into a broad, strategic collaboration with Merck that will provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
- Assure high standards of Quality in all aspects of cGMP compliance.
- Foster a culture of continuous improvement in all aspects of GMP Quality. This includes the development and administration of policies and practices which address quality issues throughout the organization.
- Monitor changes in FDA regulations which pertain to NGM Biopharmaceuticals operations on matters relating to clinical and commercial product manufacturing.
- Identify relevant compliance requirements that relate to validation, manufacturing and product testing and provide up-to- date information about regulatory requirements as well as new developments in industry practices.
- Direct company GMP based regulatory and Quality audits and serve as NGM Biopharmaceuticals representative in manufacturing based audits with the FDA and other government agencies.
- Provide guidance and direction regarding manufacturing Quality to project teams and develop, implement, maintain and monitor GMP Quality systems. These include, but are not limited to documentation, training, internal and external audits, change control, investigations, deviations and record review, as well as raw material, intermediate and finished product release.
- Assess and revise, as needed, standard operating procedures for GMP Quality functions and identify opportunities to streamline processes and systems.
- Resolve discrepancies and deviations by following best practices and providing necessary regulatory guidance.
- Develop systems to assure proper documentation of all cGMPs. This includes the following: test methods, specifications, validation protocols, final reports, change controls and Master Batch records.
- Collaborate with colleagues in the planning and use of facilities and equipment. This includes process validation in accordance with guidelines and industry best practices.
- Serve as a member of the Sr. Manufacturing Operations team and advise all levels of management on manufacturing Quality practices and issues of concern.
- Review, on an ongoing basis, all QA/QC costs which impact the delivery of products that meet Quality standards.
- Assure that all manufacturing R&D, and commercial manufacturing and distribution practices and procedures are in full compliance with applicable regulations in the US and in international markets.
- Develop and manage a budget to fulfill a comprehensive GMP Quality Management plan including new manufacturing Quality initiatives for NGM Biopharmaceuticals, Inc.
- 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 QA/QC. Management experience in both large and small companies is highly desirable.
- Strong knowledge of cGMPS, as well as other relevant US and international regulatory requirements. Experience with US FDA and/or international authority GMP inspections is preferred. Broad understanding and experience in pharmaceutical GXP is desirable.
- 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.
- Hands-on experience with ISO Quality standards and demonstrated success in project management and process improvement initiatives in the development and manufacture of pharmaceuticals.
- 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.
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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