Quality Compliance Senior Manager

4 weeks ago

Dublin, Dublin City, Ireland Amgen Full time
Overview

Quality Compliance Senior Manager at Amgen. This role is within Regulatory Compliance, supporting Inspections Lifecycle Management (ILM) at the Amgen Dún Laoghaire site. Leads preparation for, execution of, and response to Regulatory Agency and Business Partner inspections; collaborates cross-functionally to maintain inspection readiness; and develops formal response commitments and improvement actions.

What You Will Do
  • Prepare for inspections through cross-functional and cross-site collaboration with strong on-site presence to ensure perpetual inspection readiness for the ADL site.
  • Execute inspections, including direct interaction with inspectors and support in required functions.
  • Lead the generation of formal response commitments for the ADL site and cascade inspection outcomes across Amgen sites and functions.
  • Identify improvement opportunities and track commitments and actions to completion.
  • Establish and maintain best practice inspection lifecycle processes from preparation through inspection outcomes, to be applied consistently across Amgen globally.
  • Apply knowledge of current regulations, standards, and guidelines, in addition to SOP requirements, to support inspections.
  • May serve as a Subject Matter Expert (SME) for GMP/GDP topics in support of the Quality Management System, self-inspections, and regulatory documentation related to ADL site inspections/certification.
What We Expect Of You

We seek a leader with the following qualifications.

Basic Qualifications
  • High school diploma / GED with 12 years of Quality Compliance experience OR
  • Associate's degree with 10 years of Quality Compliance experience OR
  • Bachelor's degree with 6 years of Quality Compliance experience OR
  • Master's degree with 4 years of Quality Compliance experience OR
  • Doctorate degree with 2 years of Quality Compliance experience
Preferred Qualifications
  • Bachelor's Degree in Life Sciences or Engineering
  • Experience leading or participating in roles to prepare for, execute, and respond to Health Authority inspections
  • Experience auditing and defending processes during Health Authority inspections
  • 7+ years in pharmaceutical manufacturing, process development, or quality assurance with increasing responsibility and proven experience in compliance, data analysis, project management, and quality systems
  • Experience managing staff and leading cross-functional teams or programs
  • Solid understanding of quality management systems and quality control for bulk drug, drug/combination product, and finished products
  • Exposure to bulk drug and drug/combination and finished product manufacturing and QA processes
  • Experience with facility start-ups and expansions
  • Solid understanding of EU and US cGMPs and GDPs
  • Ability to work autonomously, present data clearly, and communicate effectively
  • Experience with process improvement projects
  • Structured problem-solving ability to navigate ambiguity
  • Track record of building or participating in impactful teams
  • Ability to coordinate and lead cross-functional project teams to meet expectations and timelines
  • Ability to maintain remote working relationships with teams at other Amgen sites to align to standard methodologies
What You Can Expect From Us

Amgen supports teammates' professional and personal growth and well-being. In addition to base salary, Amgen offers competitive Total Rewards Plans aligned with local industry standards.

How to Apply

Apply now for a career that defies imagination with Amgen.

Location: Dublin, County Dublin, Ireland and surrounding areas


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