Associate Director, Quality Assurance

About the role

The Associate Director, Quality Assurance leads the execution, oversight, and continuous improvement of globally governed quality system processes supporting the clinical supply chain for investigational medicinal products.

Key responsibilities

• Drive transformation initiatives in deviation management, CAPA effectiveness, change control, quality risk management, and data governance.
• Standardize and continuously improve global quality system processes to ensure inspection readiness and transparency.
• Reinforce data integrity controls to support right‑first‑time execution and regulatory confidence.
• Provide expertise to keep processes compliant with global regulatory requirements and internal standards.
• Partner cross‑functionally to identify systemic gaps, influence adoption of global standards, and implement sustainable solutions.
• Develop and monitor quality system metrics and key performance indicators.
• Author, review, and approve quality system documentation and governance materials.

Required profile

• B.S., M.S., or Ph.D. in a science or engineering discipline.
• Minimum 8 years (B.S./M.S.) or 5 years (Ph.D.) experience in pharmaceutical or biotechnology industry.
• Demonstrated experience in Quality Systems, Quality Assurance, Compliance, or related GxP‑regulated roles.
• Extensive knowledge of global GxP requirements and Pharmaceutical Quality System principles.

Required skills

• Compliance Investigations
• Data Integrity
• Deviation Management
• Good Manufacturing Practices (GMP)
• Managing Ambiguity
• Process Standardization
• Project Leadership
• Quality Assurance Systems
• Quality Compliance
• Quality Oversight
• Quality Risk Management
• Quality Systems Compliance
• Training and Development

What we offer

• Salary range $129,000 – $203,100 per year.
• Eligibility for annual bonus and long‑term incentive.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation, and sick days.
• Hybrid work arrangement.