Director, Quality Assurance Salary at Draftfcb BETA

Meet is working with a clinical stage biotechnology company looking to hire an Associate Director of CGMP Quality Assurance. Reporting to the Head of Quality, you will be working with cross-functional teams to manage external vendors and CDMOs. The role involves providing quality support and contributing to the development of quality systems. Expertise in GMP and related regulations is required. RESPONSIBILITIES: Serve as the technical expert on CGMP-related regulations and guidelines, specifically for manufacturing, testing, and controls. Review and approve drug substance and drug product manufacturing, packaging, and labeling documents within defined timelines. Lead and support external quality activities, including batch record reviews, analytical method validations, tech transfers, deviations, quality agreements, supplier qualifications, and audits. Participate in CDMO team meetings, providing quality feedback and collaborating on complex investigations for the company's global pro

Meet is working with a clinical stage biotechnology company looking to hire an Associate Director of CGMP Quality Assurance. Reporting to the Head of Quality, you will be working with cross-functional teams to manage external vendors and CDMOs. The role involves providing quality support and contributing to the development of quality systems. Expertise in GMP and related regulations is required. RESPONSIBILITIES: Serve as the technical expert on CGMP-related regulations and guidelines, specifically for manufacturing, testing, and controls. Review and approve drug substance and drug product manufacturing, packaging, and labeling documents within defined timelines. Lead and support external quality activities, including batch record reviews, analytical method validations, tech transfers, deviations, quality agreements, supplier qualifications, and audits. Participate in CDMO team meetings, providing quality feedback and collaborating on complex investigations for the company's global pro

Job Description Job Description Role Description Reporting directly to the CSO, the Director of Quality Assurance (QA) is responsible for establishing and administering quality systems supporting compliant nonclinical laboratory study Good Laboratory Practice (GLP) and or phases thereof and testing activities producing primary or secondary endpoints of clinical studies Good Clinical Laboratory Practice (GCLP). Assure Test Site Management (TSM) that facilities, equipment, personnel, methods, practices, records, and controls are in conformance of regulations. Key Responsibilities Host client and regulatory inspections including preparing responses of findings thereof. Supports organization regulatory professionals across BABM sites. Assure GLP protocol requirements are met by auditing phase specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols to evaluate regulatory compliance. Establish and ma

Position Summary: A clinical-stage biotechnology company is seeking an Associate Director of GMP Quality Assurance. Based in South San Francisco, California, the company is focused on developing therapies that treat immunological diseases and cancer. The Associate Director will report to the Head of Quality and collaborate with cross-functional teams to manage external vendors and CDMOs. The role will involve providing quality support and contributing to the development of the company’s quality systems, with a strong focus on GMP and related regulations. Key Responsibilities: Serve as the technical expert on CGMP-related regulations and guidelines, particularly for manufacturing, testing, and controls. Review and approve drug substance and drug product manufacturing, packaging, and labeling documents within defined timelines. Lead and support external quality activities, including batch record reviews, analytical method validations, tech transfers, deviations, quality agreements, suppl

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Director Pharmacovigilance Quality Assurance is a senior member of the CQA team. The Director will lead

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Director of Clinical Quality Assurance (CQA) is a senior member of the CQA team and will lead and perfor

Job Description Title: Executive Director, Clinical Quality Assurance Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody

Job Title: Director, Clinical Quality Assurance 3 days onsite in South San Francisco per week Relocation Assistance provided Job Overview: The Director of Clinical Quality Assurance (GCP) will ensure the quality of clinical programs throughout their lifecycle, including oversight, risk assessment, and compliance with regulatory standards. This role will drive the quality strategy and provide operational guidance to development teams. Key Responsibilities: Develop and maintain GCP QA programs, ensuring compliance with health authority regulations and guidelines. Lead audit planning and execution, provide quality oversight for clinical documents, and ensure inspection readiness. Support clinical service provider selection, manage KPIs, and guide cross-functional teams on quality matters. Qualifications: Bachelor's or advanced degree in Biology, Chemistry, or related field, with 10+ years of GCP/GVP QA experience. Strong knowledge of FDA, ICH, and global health authority regulations, with