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Associate Director, QA CMO Oversight

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BioMarin Pharmaceutical

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Location:
Ireland , Cork

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Associate Director, QA CMO Oversight is a key role as part of External Quality, Global External Operations (GEO) and Global Supply Chain (GSC) organizations. The position will provide risk-based quality oversight of Contract Manufacturing Organisations (CMOs) to ensure compliance with cGMP and regulatory requirements, and will act as the Quality Single Point of Contact (SPOC) within Global External Operations (GEO), partnering with CMOs and internal stakeholders to maintain product quality, patient safety, and inspection readiness.

Job Responsibility:

  • Operational Management: Ensure overseeing daily quality operations of the QA Managers and Qualified Person(s)
  • Team Leadership: Lead, mentor, and develop a team of Quality Managers and Qualified Persons
  • Ensure compliance with applicable GMP Guidelines and Regulations
  • Ensure CMOs are inspection-ready
  • Monitor and report and analyse quality key performance indicators (KPIs) metrics, trends, and CAPAs
  • Collaborate with cross-functional teams to ensure alignment on GMP requirements and quality standards
  • Ensure development and delivery of GMP training programs
  • Ensure maintenance of documentation and records to support GMP compliance
  • Support global initiatives and harmonization efforts
  • Budget Management: Develop and manage the regional quality budget
  • Compliance: Ensure compliance with all relevant regulations
  • Process Improvement: Identify and implement quality process improvements
  • Stakeholder Collaboration: Collaborate with internal and external stakeholders
  • Technology Utilization: Leverage global quality tools and systems
  • Change Leadership: Support and drive the change management requirements

Requirements:

  • Bachelor’s or advanced degree in Pharmacy, Chemistry, Biochemistry, Microbiology, or related scientific discipline
  • Eligible EU Qualified Person (QP) or fully credentialed QP strongly preferred
  • 8+ years of experience in pharmaceutical quality assurance, including CMO oversight
  • At least 3 years people management experience
  • In-depth knowledge of GMP Guidelines and Regulations
  • Detail-oriented, analytical thinker, problem-solver
  • Strategic mindset with hands-on operational execution
  • Strong leadership and team management skills
  • Excellent communication and interpersonal skills
  • Proven ability to lead change initiatives and drive improvements
  • Proficiency in QMS tools and systems
  • Solid understanding of external quality oversight principles
  • Ability to effectively work autonomously and independently
  • Understanding of Quality Tools: e.g., Veeva QMS, SAP, or like technologies

Additional Information:

Job Posted:
December 26, 2025

Expiration:
January 09, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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