Sr Associate Compliance

Career Category

Job Description

Join our team atAMGEN Capability Center Portugal number 1 company in Best WorkplacesTMhttps:// in Portugal in 2024 (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 500 talented people and more than 40 different nationalities diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity Data & Analytics Digital Technology and Innovation Finance General & Admin Human Resources Regulatory Affairs and many Lisbons city center our AMGEN office fosters innovation excellence and inspiration. Come thrive with us at AMGEN supporting our mission To Serve Patients. What we do at AMGEN matters in peoples lives.

SR ASSOCIATE COMPLIANCE

LIVE

WHAT YOU WILL DO

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

Your responsibilities will include:

• 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.

WIN

WHAT WE EXPECT OF YOU

You are a structured detailoriented professional with strong analytical and problem-solving skills. You work autonomously meet deadlines consistently and communicate effectively across teams and geographies.

Minimum requirements

• Bachelors degree or equivalent 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 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).

Preferred requirements

• 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 solutionoriented and able to drive tasks through to completion.
• High attention to detail and strong selfmanagement.

THRIVE

WHAT YOU CAN EXPECT OF US

As we work to develop treatments that take care of others we also care deeply for our teammates well-being and growth.

• 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.

Objects in your future are closer than they us.

EQUAL OPPORTUNITY STATEMENT

AMGEN is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.