Director of Quality Excellence

7 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeQuality Full time €98,353 - €126,580
Senior Quality Director

About the Role:

We are seeking a Senior Quality Director to join our organization. As a key member of the leadership team, you will be responsible for leading quality initiatives and ensuring compliance with regulatory requirements.

Key Responsibilities:

  • Act as the primary Qualified Person (QP) for aseptically manufactured, parenteral products.
  • Provide guidance and support to QPs and other functions based on past experiences and knowledge.
  • C coach and mentor quality colleagues to develop problem-solving, decision-making, and critical-thinking skills.
  • Evaluate multiple data sources and perspectives to accurately characterize problems and opportunities; solve complex problems with little precedent.

The Ideal Candidate:

  • University Degree in Pharmacy or Science related discipline with post graduate course.
  • Relevant experience working in the pharmaceutical or Biotechnology Industry over a minimum of 10 years.
  • Highly organized with good time management and prioritization skills.
  • Critical thinking and evaluation of process problems.
  • Excellent verbal and written communication skills.
  • Patient and results-focused.
  • Good leadership skills and highly motivated.
  • Collaborative team player.

What We Offer:

  • Maintain close contact and familiarity with Amgen Quality systems and programs used at other Amgen sites.
  • Act as the primary liaison to HPRA.
  • Support inspection readiness, including developing playbooks and reviewing responses to GMP inspections.
  • Conduct vendor audits and site visits as required.
  • Oversee the evaluation of quality and distribution complaints.
  • Lead projects and improvement efforts, including product launches.

Requirements:

  • Maintain close contact and familiarity with Quality systems and programs used at other sites.
  • Act as the primary liaison to regulatory agencies.
  • Support inspection readiness, including developing protocols and reviewing responses to regulatory inspections.
  • Conduct audits and site visits as required.
  • Oversee the evaluation of quality and distribution issues.
  • Lead projects and improvement efforts, including product launches.

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