Executive Director, Quality in Netherlands at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Executive Director, Quality in the Netherlands.

This senior leadership role is responsible for defining and overseeing the Quality strategy across European operations, ensuring full compliance with EU regulatory expectations across GxP domains. You will act as the primary Quality authority in the region, shaping a robust and inspection-ready Quality Management System that supports both clinical and commercial activities. The role requires close partnership with global and regional functions including Regulatory Affairs, Technical Operations, Supply Chain, and Clinical Operations to ensure end-to-end quality integration across the product lifecycle. You will also serve as the key interface with European health authorities, leading inspection readiness and regulatory interactions. This is a highly strategic position with both governance and operational accountability, influencing how quality systems are designed, implemented, and continuously improved. It is a critical leadership role in a fast-paced, science-driven environment focused on advancing innovative oncology therapies for patients.

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and readiness for clinical-to-commercial transition.
• Act as the primary Quality representative in Europe, engaging with regulatory authorities such as EMA and national agencies.
• Establish, maintain, and continuously improve the EU Quality Management System in compliance with EU GMP, GDP, GCP, and ICH guidelines.
• Oversee quality system processes including deviations, CAPAs, change control, risk management, complaints, and documentation governance.
• Ensure Quality oversight of MAH responsibilities including product lifecycle management, recalls, and regulatory commitments.
• Lead inspection readiness activities and manage regulatory inspections and audits across European operations.
• Oversee external partners such as CMOs, 3PLs, and distributors, ensuring compliance through quality agreements and performance monitoring.
• Define and govern EU Qualified Person (QP) and GDP frameworks, ensuring compliant batch certification and distribution oversight.
• Support regulatory submissions and lifecycle activities with strong quality input across CMC and related documentation.
• Drive cross-functional collaboration to ensure integrated execution across supply chain, regulatory, and technical operations.

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).
• 20+ years of experience in GxP Quality within the pharmaceutical or biotech industry.
• Proven track record of building, scaling, and leading Quality organizations in regulated environments.
• Deep expertise in EU regulatory frameworks including EMA requirements, EU GMP/GDP, and ICH guidelines.
• Strong experience in GMP/GDP environments with exposure to clinical and commercial operations.
• Demonstrated leadership of regional or global teams in matrixed organizations.
• Strong stakeholder management skills with ability to influence across senior cross-functional groups.
• Excellent communication and regulatory interaction skills with European health authorities.

This role offers the opportunity to shape and lead Quality strategy across European operations in a highly regulated and scientifically advanced environment. You will be responsible for ensuring that all quality systems meet the highest standards of compliance while enabling the development and commercialization of innovative oncology therapies. Acting as the senior Quality authority in the region, you will interface directly with European regulators and oversee inspection readiness across all activities. The position requires strong collaboration with global and regional stakeholders to ensure seamless integration of quality across the product lifecycle. You will also play a key role in managing external manufacturing and distribution partners, ensuring consistent compliance across the supply chain. This is a high-impact leadership role where strategic vision, regulatory expertise, and operational excellence converge.

• Competitive executive-level compensation package (salary aligned with experience and market standards)
• Performance-based incentives and potential equity participation
• Comprehensive health, dental, and vision insurance coverage
• Retirement savings plans and financial wellness support
• Flexible remote working arrangement (#LI-Remote)
• Generous paid time off and holiday allowance
• Professional development opportunities and leadership growth support
• Opportunity to contribute to cutting-edge oncology innovation with global impact