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Uniphar

Outsourced pharmaceutical, medtech, and supply-chain services

Quality Director - Group Global Quality

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeDublin, IrelandNo salary listed

About the Job

Requirements

  • A bachelor's or master's degree in Life Sciences, Pharmacy, IT, Engineering, or a related discipline is required.
  • At least 10 years of experience in the pharmaceutical, medical device, or life sciences industries, including at least 5 years in a senior leadership role in computer system validation, is required.
  • A deep understanding of quality management system frameworks, GxP compliance, and international regulatory requirements, including FDA, EMA, HPRA, ISO 13485, 21 CFR Part 11, and GAMP 5, is required.
  • Proven expertise in vendor management, supplier quality, and audit oversight is required.
  • Strong experience in computer system validation and computerized systems lifecycle management is required.
  • Demonstrated success leading cross-functional teams and managing complex global projects is required.
  • The candidate must be fluent in English.
  • The candidate should be comfortable working in a fast-moving entrepreneurial culture that requires rapid responses.
  • The candidate should be comfortable networking and building business relationships.

Responsibilities

  • Lead the design, implementation, and continuous improvement of the global quality management system.
  • Ensure local quality systems align with global policies and procedures.
  • Monitor compliance with GxP, ISO, and applicable regulatory requirements, including FDA, EMA, and MHRA.
  • Roll out and act as gatekeeper for the global vendor management system.
  • Oversee the global vendor management system to ensure supplier qualification, risk assessment, and ongoing performance monitoring meet regulatory and business standards.
  • Develop metrics and dashboards to track and report supplier quality performance.
  • Define and implement global quality systems strategies that support compliance, scalability, and business efficiency.
  • Monitor regulatory trends and evolving quality requirements, and update global systems and processes as needed.
  • Support internal and external audits and regulatory inspections by ensuring readiness and consistency across global operations.
  • Champion continuous improvement to improve efficiency while maintaining regulatory standards across group GMP sites.
  • Review and streamline processes by enabling technology solutions.
  • Provide strategic and operational leadership to global and regional teams responsible for quality management systems, vendor management systems, and GMP processes.
  • Build cross-functional partnerships with Quality Leaders, IT, Operations, Legal, and Commercial teams.
  • Lead or contribute to quality governance forums and cross-functional project steering committees.
  • Mentor, coach, and develop quality systems talent across the organization.
  • Serve as a member of the Global Quality Leadership Team.
  • Create a culture of excellence within the quality team.
  • Manage and grow a team of quality experts, fostering collaboration and accountability.
  • Deliver the global quality management system and gatekeeper tool across all Uniphar entities.
  • Design and deliver an internal and external quality audit program.
  • Develop a cross-geographical quality team.
  • Harmonize quality management procedures across Uniphar entities.
  • Embed a One Uniphar quality culture across Uniphar entities.

Desired Qualifications

  • Experience working in a matrixed, multinational organization is preferred.
  • Additional European languages are highly desirable.

About the Company

Uniphar

Outsourced pharmaceutical, medtech, and supply-chain services

Uniphar is a diversified healthcare services provider offering outsourced services to pharmaceutical, medtech, and biotech manufacturers across three divisions: Uniphar Pharma, Uniphar Medtech, and Uniphar Supply Chain + Retail. Uniphar Pharma covers the drug lifecycle from development to commercialization, including sourcing hard-to-find medicines and supporting biotech launches globally. Uniphar Medtech provides outsourced sales, marketing, and distribution for medical devices; Supply Chain + Retail handles pre-wholesale/wholesale distribution and runs pharmacy brands like Allcare, Hickey's, and McCauley. It competes by leveraging a global infrastructure, a diversified services portfolio, and growth through acquisitions and high-tech distribution hubs to reach patients in over 180 countries and streamline supply chains so medicines are more accessible worldwide.

Company size
501-1,000
Company stage
IPO
Headquarters
Dublin, Ireland
Founded
1994

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