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Senior Manager Quality Compliance External Affairs

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Amgen

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Location:
Ireland , Dun Laoghaire

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

The Senior Manager Quality Compliance External Affairs will enhance quality, compliance, and regulatory flexibility by providing leadership and support of external activities impacting Amgen’s Operations function with link to Regulatory Affairs-CMC, with a regional focus on Japan & Asia Pacific (JAPAC).

Job Responsibility:

  • Representing Amgen in industry trade, individual based associations and/or academia
  • Networking with peers from other companies and regulatory authorities
  • Taking opportunities to lead teams in and represent for these external professional bodies and organizations
  • Communicating Amgen’s perspectives and knowledge to regulators, governments, associations, and academia
  • Support organizing educational site visits of regulatory / governmental officials
  • Supporting or leading the commenting on regulatory documents incl. pharmacopoeias
  • National and international travel required (up to 20%)
  • Networking across various Amgen functions
  • Answering day-to-day questions on regulatory trends and interpretation of regulatory documents
  • Providing training / education sessions to enhance the knowledge on regulatory and technical expectations
  • Gathering and delivering timely competitive intelligence overviews
  • Coordinating and leading Key External Initiatives and/or Organizations
  • Identifying external engagement opportunities for Amgen talents, motivating and proactively providing coaching
  • Benchmark and share regulatory, quality and GxP intelligence / inspection trends
  • Interface with the Amgen organization, sites, and leadership to update and alert regulatory and inspection requirements and trends

Requirements:

  • Minimum of 12-16 years of experience in pharmaceutical manufacturing / quality
  • Experience in working with and representing a company in external organizations
  • Ability to interpret, analyze, and communicate information, not simply summarize
  • To manage / lead multiple programs and/or projects
  • Understanding of global regulatory Quality requirements (incl. GxP, Supply chain, Medical Device / Combination products, Pharmacopoeia)
  • Knowledge in Pharmaceutical Quality Systems / Quality Management Systems
  • Proven ability to understand technical, scientific, and medical information
  • Involvement in external activities representing a company / agency
  • Computer and database skills

Nice to have:

  • Recognition as a key speaker at meeting / conferences on current Quality topics
  • Ability to develop training and presentation material
  • Capability for onboarding skills for staff/new employee/new coworkers in external teams
  • Languages: fluent in English (written and spoken)
  • potentially an additional language, in best case Mandarin or Japanese

Additional Information:

Job Posted:
May 16, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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