Sr Associate Compliance Job at Amgen (Lisbon)

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.

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

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)

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

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