Associate Director, Quality Assurance (Pharma)
Location: Redwood City, CA (hybrid model)
Type of role: FTE, Full time Salary: plus bonus and equity
Our start-up Biotech client is seeking an Associate Director / Director Quality Assurance to join their growing company. Ideal candidate will be a hands-on Director who brings broad QA experience in the biologics industry.
- 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 as they relate 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 audit reports for all CROs, CDMOs, and GMP vendors and internal departments.
- Coordinate and perform virtual or on-site audits as needed
- Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition.
- Lead and ensure inspection readiness activities for all internal and external entities
- Host GMP inspections. Follow up to any responses and CAPAs
- Develop, implement, and manage the quality management systems including vendor management, change control, product label review, risk management, GXP computer systems, deviation and CAPA systems
- Develop and implement overall GXP strategy, performance metrics, analytics, and reports
- Ensure and record periodic SOP trainings for all employees including onboarding FTEs and contractors in the GXP system as applicable
- Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical setting.
- Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP regulations and current industry standards.
- Experience in designing and implementing quality systems and risk management tools
- Experience interacting with and managing CMOs for DS and DP especially biological products
- Experience leading/hosting US and international health authority inspections/interactions
- Excellent interpersonal, verbal, and written communication skills are critical in our collaborative work environment
- Must demonstrate high organizational, prioritization and management proficiencies
- Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities