Sr. Associate Compliance Breda • Talentmark

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Position Overview As Senior Associate Compliance, you play a key role in safeguarding the quality and authenticity of Amgen’s products throughout the EU Regional Supply Chain. You will embed and uphold the principles of Good Distribution Practice (GDP) and the Falsified Medicines Directive (FMD) within the organization’s operations—ensuring that patients continue to receive safe, effective, and verified medicines.

Key Responsibilities

• Temperature Excursions (TEs): Own and manage temperature assessment records across the EU supply chain.
• Deviation Management: Lead root cause analysis sessions and manage both minor and major deviation records.
• Corrective and Preventive Actions (CAPA): Own and oversee CAPA and CAPA Effectiveness Verification (CAPA EV) records to ensure timely and effective implementation.
• Product Issues: Manage missing product notifications and coordinate Event Review Team meetings when necessary.
• Audits & Inspections: Support audits and inspections related to EU distribution processes, including at affiliate locations.
• Recall Readiness: Contribute to product recall activities and annual mock recall exercises.
• Document Control: Serve as Subject Matter Expert (SME) in document management and control systems.
• Data Accuracy: Ensure real-time and accurate data entry in Smartsheet for deviations, TEs, and product-related events.
• Travel: Occasional travel may be required within the region.

Minimum Qualifications

• Bachelor’s degree in Life Sciences plus 2+ years of experience in GMP/GDP compliance
  OR
  In the absence of a Life Sciences degree, 4+ years of experience in GMP/GDP compliance
• Solid understanding of Quality Assurance principles, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP)
• Proficient in English (written and spoken); Dutch is highly preferred
• Strong experience with Quality Management Systems (e.g., TrackWise, Veeva) and MS Office applications (Word, Excel, etc.)

Preferred Qualifications

• Experience supporting regulatory audits and inspections
• Strong technical writing and documentation skills

Key Competencies

• Clear and effective communicator across levels, functions, and countries
• Applies a risk-based approach to decision-making and escalation
• Uses an analytical, evidence-based mindset to solve problems
• Sees the bigger picture—able to connect dots across issues and involve relevant stakeholders
• Proactive in identifying solutions and driving them forward
• Works independently and meets deadlines with discipline and precision
• Maintains high attention to detail and quality standards in all work