Director, Quality Assurance (Pharma)

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.

Requirements

• 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

Benefits

• Bonus
• Equity