Title: AD/Director, Quality Assurance, Pharma Location: Redwood City, CA Type of role: FTE, Full time Salary: 181K - 214K plus bonus and equity Our direct client is seeking an Associate Director / Director of Quality Assurance to join their growing company. Job Description Develop and implement GXP including GMP quality systems in accordance with ICH, FDA, EMA, and global competent authority regulations and industry guidance. Review all GXP documents/reports, especially those related to method development, validation activities, and PPQ generation results. Provide compliance oversight for internal and contracted external GXP activities. Coordinate and implement audit plans and reports for CROs, CDMOs, GMP vendors, and internal departments. Conduct virtual or on-site audits as needed. Oversee GMP CDMOs, including quality agreements, and manage GMP batch record review and disposition. Lead inspection readiness activities for internal and external entities. Host GMP inspections and follow up with responses and CAPAs. Develop and manage quality systems including vendor management, change control, product label review, risk management, GXP computer systems, deviations, and CAPA systems. Develop and implement GXP strategy, performance metrics, analytics, and reports. Ensure periodic SOP trainings for all employees, including onboarding FTEs and contractors. Qualifications Bachelor’s degree in biological sciences or related field with at least 10 years’ experience in a pharmaceutical setting. Extensive knowledge of worldwide GXP regulatory requirements, industry practices, and application skills. Experience with GMP regulations and current standards. Experience designing and implementing quality systems and risk management tools. Experience managing CMOs for DS and DP, especially for biological products. Experience leading US and international health authority inspections. Excellent interpersonal, verbal, and written communication skills. Strong organizational, prioritization, and management skills. Ability to work effectively in a fast-paced small company environment and adapt to changing priorities.

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