Senior Director, Head of Quality, International

This is a fully remote position, open to applicants in Netherlands.

📋 Description

• Oversee quality for infigratinib and act as the designated Responsible Person for the entity’s wholesale distribution authorization.

• Report to the Head of Quality, QED, while maintaining a dotted line to the local managing director.

• Execute Responsible Person responsibilities, encompassing distribution release, recall decisions, and compliance with Good Distribution Practice (GDP).

• Lead and cultivate the quality team, which includes the deputy RP, QA compliance/QMS, QA operations/GDP, and QP.

• Manage and enhance the Quality Management System across Skeletal Dysplasia assets.

• Direct WDA application and IGJ inspection preparedness; facilitate readiness for potential MIA.

• Own and manage the quality agreement matrix that includes CSPs, 3PLs, distributors, and intercompany interfaces.

• Serve as the QA liaison and oversight for contract service providers.

• Evaluate deviations, change controls, supplier notifications, batch records, specifications, analytical and microbiological methods, stability protocols, label proofs, validation protocols, reports, and analytical test results.

• Oversee lot release activities and communicate release timelines.

• Report on manufacturing deficiencies and non-conformances, ensuring prompt resolution.

• Assist with CMC sections of regulatory and quality documentation.

• Support the handling of returns, rejected or falsified products, and medicinal-product recalls.

• Supervise GDP/GMP activities for APIs, WDA/API registration, vendor qualification, audits, internal training, data integrity, and EU/ROW inspections.

• Write and review governing procedures such as SOPs and work instructions.

• Participate in internal and external project team meetings.

⛳️ Requirements

• BS/MS degree, preferably in operations, science, or pharmacy.

• Diploma, certificate, or other proof of formal qualifications upon completion of GDP/GDP-API training required for registration as an RP by the competent authorities in the Netherlands.

• Over 10 years of experience in pharmaceutical quality, with substantial GDP/distribution quality expertise.

• Prior appointment as, or eligibility to become, a Responsible Person is strongly preferred.

• Experience leading regulatory inspections with EU competent authorities; IGJ preferred.

• Experience in managing third-party vendors (CMOs, CTLs, 3PLs, etc.).

• Relevant knowledge and experience concerning the distribution of medical products.

• Strong comprehension of supply chain, supplier management, and inventory management.

• Extensive understanding of US/EU GMPs/GDPs and related guidance.

• Experience in a highly regulated environment.

• Proven leadership in managing quality teams and experience in establishing quality functions or systems.

• Familiarity with EU regulations, particularly IGJ, regarding wholesale distribution of medicines.

• Strong organizational and time management skills with the ability to prioritize tasks effectively.

• Excellent analytical and problem-solving abilities with a keen eye for detail.

• Proficient in Microsoft Office, Google Docs, and similar document/presentation tools.

• Basic understanding of data concepts and ERP systems like SAP.

• Willingness to uphold company core values and embrace a diverse corporate culture.

🏝️ Benefits

• Market-leading compensation.

• Hybrid work model with flexibility.

• Career development opportunities through regular feedback, continuous education, and professional development programs.

• Financial rewards, peer-to-peer recognition, and growth opportunities.

• 30% travel expected.

• Flexible “take-what-you-need” paid time off and company-paid holidays.

• Comprehensive paid medical and parental leave.

• Employee Stock Purchase Program (ESPP).

• Health Savings Account (HSA) with annual employer contributions and Flexible Spending Accounts (FSA).

• Fertility and family-forming benefits.

• Expanded mental health support including therapy and coaching resources.

• 401(k) plan with employer matching.

• Pre-tax commuter benefits for transit and parking.

• Referral bonus for successful candidate hires.

• Subsidized lunch and parking on in-office days.

• 100% employer-paid medical, dental, and vision premiums for you and your dependents.

• Opportunities for internal mobility and skill development.

• Access to LinkedIn Learning, LifeLabs, and BetterUp Coaching.