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Sr Associate Compliance

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Amgen

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Location:
Portugal , Lisbon

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Category:
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Contract Type:
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Salary:

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Job Description:

As a Sr. Associate Compliance, you will play a key role in ensuring compliance and product quality within the EU Regional Supply Chain network.

Job Responsibility:

  • Embedding the principles of Good Distribution Practices (GDP) and the Falsified Medicines Directive (FMD) in the EU Regional Supply Chain to ensure product quality and authenticity
  • Owning and managing temperature excursion records
  • Owning and managing minor and major deviation records, including leading root cause analysis sessions
  • Owning and managing CAPA and CAPA EV records, ensuring timely and effective implementation
  • Owning, managing, and facilitating Risk Assessment evaluations
  • Managing missing product notifications, including leading Event Review Team meetings when applicable
  • Supporting audits and inspections involving the EU supply chain, including affiliate-level audits
  • Supporting product recalls and annual mock recall exercises
  • Ensuring an up-to-date Smartsheet for minor/major deviations, CTETS, and missing products
  • Acting as an SME for temperature excursion assessments, deviation management, CAPA & EV processes

Requirements:

  • Bachelor’s degree or equivalent in Life Sciences plus 2 years of experience in GMP/GDP compliance
  • In the absence of a Life Sciences degree, 4+ years of experience in GMP/GDP compliance
  • Solid knowledge of Quality Assurance, GMP, and GDP
  • Fluency in English
  • Dutch is preferred
  • Strong skills with word processing tools, databases, spreadsheets, and Quality Management Systems (e.g., TrackWise, Veeva)

Nice to have:

  • Experience supporting audits and inspections
  • Strong technical writing skills
  • Effective communication skills across multiple levels and geographies
  • Ability to apply a risk-based approach to decision-making and escalation
  • Analytical, evidence-based mindset
  • Ability to identify connections between issues and bring the right stakeholders together
  • Proactive, solution‑oriented, and able to drive tasks through to completion
  • High attention to detail and strong self‑management
What we offer:
  • Vast opportunities to learn, develop, and move up and across our global organization
  • Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
  • Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
  • Flexible work arrangements

Additional Information:

Job Posted:
January 22, 2026

Work Type:
Hybrid work
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