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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive knowledge of GDP and GMP regulations, with proven leadership in managing quality teams and systems within the pharmaceutical industry. Capable of overseeing quality management processes, regulatory inspections, and vendor qualifications while ensuring compliance with EU and US standards.
Highest-signal resume keywords
Responsible Person ExperiencePharmaceutical Quality ManagementGDP/GMP ComplianceRegulatory Inspection LeadershipVendor Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management SystemDeviation ReviewChange Control ManagementBatch Record ReviewAnalytical Method ValidationStability ProtocolsSOP WritingQuality Agreement Matrix ManagementDistribution ReleaseRecall Decision Making
Soft Skills
LeadershipAnalytical SkillsProblem-SolvingTime ManagementAttention to Detail
Tools & Technologies
Microsoft OfficeGoogle DocsERP SystemsSAP
Certifications & Qualifications
GDP Training CertificationResponsible Person Registration
Industry Keywords
Pharmaceutical QualitySkeletal DysplasiaWholesale DistributionEU RegulationsIGJ ComplianceThird-Party Vendor ManagementMedical Product DistributionSupply Chain ManagementInventory ManagementRegulated Environment
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Lead quality for infigratinib and serve as designated Responsible Person for the entity’s wholesale distribution authorisation
- Report to the Head of Quality, QED, with a dotted line to the local managing director
- Perform Responsible Person duties including distribution release, recall decisions, and GDP compliance
- Lead and develop the quality team, including deputy RP, QA compliance/QMS, QA operations/GDP, and QP
- Manage and improve the Quality Management System across Skeletal Dysplasia assets
- Lead WDA application and IGJ inspection readiness; prepare potential MIA readiness
- Own the quality agreement matrix covering CSPs, 3PLs, distributors, and intercompany interfaces
- Provide QA liaison and oversight for contract service providers
- Review deviations, change controls, supplier notifications, batch records, specifications, analytical and microbiological methods, stability protocols, label proofs, validation protocols, reports, and analytical test results
- Manage lot release activities and communicate release schedules
- Communicate manufacturing deficiencies and non-conformances and ensure timely resolution
- Assist with CMC sections of regulatory and quality documents
- Support returns, rejected or falsified products, and medicinal-product recalls
- Oversee 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
What you’ll need- BS/MS degree preferably in operations, science, pharmacy
- Diploma, certificate, or other evidence of formal qualifications on completion of GDP/GDP-API training required for registration as an RP by the competent authorities in the Netherlands
- 10+ years in pharmaceutical quality, including significant GDP/distribution quality experience
- Prior appointment as, or eligibility to be, a Responsible Person strongly preferred
- Experience leading regulatory inspections with EU competent authorities; IGJ preferred
- Experience managing third-party vendors (CMOs, CTLs, 3PLs, etc.)
- Relevant knowledge and experience related to distribution of medical products
- Strong understanding of supply chain, supplier management, and inventory management
- Extensive knowledge of US/EU GMPs/GDPs and associated guidance
- Experience working in a highly regulated environment
- Proven leadership of quality teams and experience building quality functions or systems
- Understanding of EU, particularly IGJ, regulations for wholesale distribution of medicines
- Strong planning and time management skills with ability to prioritize workload
- Excellent analytical and problem-solving skills with keen attention to detail
- Proficiency in Microsoft Office, Google Docs, and similar document/presentation tools
- Basic understanding of data concepts and ERP systems such as SAP
- Willingness to embrace company core values and diverse corporate culture
Benefits
Comp & perks- Market leading compensation
- Hybrid work model with flexibility
- Career development 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 & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- 401(k) with employer match
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Internal mobility and skill development opportunities
- LinkedIn Learning, LifeLabs, and BetterUp Coaching