Vice President Quality Assurance

Responsibilities

• Define and execute the long-term strategic vision and performance objectives for the company’s integrated GxP Quality organization across GMP, GCP, GVP, and GDP activities.
• Provide enterprise-level leadership for Quality strategy, compliance governance, and inspection readiness across development, clinical, pharmacovigilance, manufacturing, and distribution operations.
• Ensure consistent, proactive GxP compliance across internal and external manufacturing operations, clinical programs, pharmacovigilance activities, and distribution networks.
• Maintain robust Quality systems, including deviation management, CAPA, change control, complaints, audits, and management review.
• Provide Quality oversight for internal manufacturing, external manufacturing partners, clinical trials, pharmacovigilance activities, supplier quality, and supply chain operations.
• Drive continuous improvement initiatives focused on risk management, right-first-time execution, and KPI-driven Quality performance.
• Support organizational scale-up initiatives including clinical expansion, new product introductions, technology transfers, and operational growth.
• Partner closely with Manufacturing, Quality Control, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Supply Chain, and Technical Operations to ensure strong cross-functional alignment.
• Operate as both a strategic leader and a hands-on contributor, providing guidance, decision-making, and direct engagement in key Quality activities as appropriate for a growing organization.
• Build, mentor, and develop Quality leadership and staff to support organizational growth and succession planning.
• Provide executive oversight of Quality budgets, headcount planning, and strategic investments in systems and capabilities.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline.
• Minimum of 15 years of experience in pharmaceutical GxP Quality, with leadership responsibility spanning multiple GxP domains such as GMP, GCP, GVP, and/or GDP.
• At least 5 years in a senior Quality leadership role overseeing commercial and/or clinical Quality organizations.
• Deep knowledge of global GxP regulations and Quality systems across manufacturing, clinical development, pharmacovigilance, and distribution activities.
• Demonstrated success leading regulatory inspections and managing health authority interactions.
• Prominent strategic, analytical, and decision-making capabilities.
• Exceptional leadership, communication, and stakeholder management skills.