Global Quality Director - Strategy & QMS Lead

Uniphar

Ireland

Remote

EUR 150,000 - 190,000

Full time

7 days ago
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Job summary

Uniphar is seeking a Quality Director to lead the Group Global Quality function and harmonize quality management across all entities. You will shape the global QMS, ensure GxP and regulatory compliance, and drive continuous improvement across GMP sites.

Reporting to the Technical Operations Director, you will build and mentor a global quality team, align local systems to global policies, and oversee vendor management and audit readiness, ensuring scalable and compliant operations.

Qualifications

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, IT or Engineering, or related discipline.
  • Minimum of 10 years in pharmaceutical, medical device or life sciences with at least 5 years in a senior CSV leadership role.
  • Deep understanding of QMS, GxP compliance, and international regulatory requirements (FDA, EMA, HPRA, ISO 13485, 21 CFR Part 11, GAMP 5).
  • Proven expertise in vendor management, supplier quality, and audit oversight.
  • Strong experience in Computer System Validation (CSV) and system lifecycle management.
  • Demonstrated success leading cross-functional teams and managing global projects.

Responsibilities

  • Lead design, implementation, and continuous improvement of Uniphar’s global QMS.
  • Ensure alignment of local quality systems with global policies and procedures; monitor compliance with GxP and regulatory requirements.
  • Roll out Global Vendor Management System and oversee supplier qualification, risk assessment, and performance.

Skills

QMS
Vendor management
Leadership
Stakeholder engagement
Continuous improvement

Education

Bachelor’s or Master’s in Life Sciences/Pharmacy/IT/Engineering

Tools

CSV
GAMP 5
Vendor Management System (VMS)

Job description

Uniphar is seeking a Quality Director to lead the Group Global Quality function and harmonize quality management across all entities. You will shape the global QMS, ensure GxP and regulatory compliance, and drive continuous improvement across GMP sites.

Reporting to the Technical Operations Director, you will build and mentor a global quality team, align local systems to global policies, and oversee vendor management and audit readiness, ensuring scalable and compliant operations.

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