AD/Director, Quality Assurance - AdeptSource (Adeptsource Inc) : Job Details

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.

• 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.

• 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.