We are seeking an Executive Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness. This role ensures compliance with cGMP regulations, company policies and procedures, and industry standards, while deliberately designing quality systems that enable speed, clarity, and confident decision-making as the company scales.

The Executive Director partners closely with cross-functional teams and external manufacturing and testing partners, ensuring high standards of product quality and data integrity across GMP operations. They will build and lead a high-performing GMP QA team, provide strategic oversight of audits and inspections, and serve as a trusted advisor to senior leadership on GMP QA risk management. This position reports to the Head of QA.

Responsibilities:

• Head of GMP QA and member of the QA Leadership Team
• Build, lead, and scale a high-performing GMP QA team
• Develop and execute the GMP QA functional strategy, ensuring alignment with company objectives and evolving clinical-to-commercial needs
• Establish a clear GMP QA vision that enables inspection readiness, scalability, and sustainable operations
• Provide oversight of GMP QA systems, including deviations, investigations, CAPAs, change control, complaints, and product disposition
• Ensure compliance with applicable global GMP regulations and standards (e.g., FDA, EMA, ICH)
• Lead organizational readiness for GMP internal audits and regulatory inspections
• Provide strategic oversight of GMP QA across CMOs, CDMOs, and external testing partners
• Ensure effective quality agreements, oversight models, escalation pathways, and performance metrics are in place and actively managed
• Exercise sound judgment in resolving quality issues with external partners in a timely and compliant manner
• Engage effectively with leadership and key cross-functional partners, bringing forward clear recommendations and risk-based perspectives
• Lead the development and presentation of Quality Management Review meetings for GMP QA to highlight compliance needs and foster continuous improvement initiatives supporting speed, clarity, and scalability

Experience:

• 15+ years of progressive GMP QA experience within pharmaceutical, biotechnology, and/or medical device environments, with deep understanding of global GMP regulations across clinical and commercial operations
• Proven track record leading GMP QA organizations through the transition from clinical development to commercial manufacturing, including launch readiness and post-approval operations
• Demonstrated success building, scaling, and sustaining GMP Quality Systems to support commercial supply, including serving as functional lead for electronic Quality Management Systems (eQMS) with accountability for system strategy, governance, and compliance across internal teams and external partners
• Extensive experience overseeing external manufacturing and testing partners, and directly leading regulatory inspections and interactions with global health authorities
• Significant leadership experience, including managing managers and senior-level professionals; effective at coaching and developing leaders through change and uncertainty
• Ability to create and clearly articulate a GMP QA vision aligned with company strategy, establish trust and credibility across teams, and set clear direction while adapting leadership style to organizational and individual needs
• Sound, unbiased judgment in complex and ambiguous situations; makes pragmatic, well-reasoned decisions, takes full ownership of outcomes, proactively addresses challenges, seeks feedback, and continuously adapts strategies based on evolving risks and business needs
• Strong written and verbal communication skills
• Ability to operate effectively in a fast-paced, evolving environment with incomplete information
• Demonstrated commitment to company values and ethical decision-making
• Position requires up to 25% travel, including domestic and international travel to vendor and manufacturing partner sites

The anticipated salary range for candidates for this role will be $270,000-$300,000. Factors include but are not limited to relevant years of experience, educational background, and geography.