Director of Quality System

2 days ago

Dublin, Dublin City, Ireland Uniphar Group Full time

Join to apply for the Director of Quality System role at Uniphar Group

Citywest, Ireland — Full Time Permanent

Overview

Director level position responsible for leading and improving Uniphar's global Quality Management System (QMS), vendor management systems, and computer system validation (CSV) across the enterprise. Partners with IT and business stakeholders to ensure systems are validated, compliant, secure, and effectively governed.

Key Responsibilities
  • Lead the 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, ISO, and applicable regulatory requirements (e.g., FDA, EMA, MHRA).
  • Roll out and govern the Global Vendor Management System (VMS).
  • Oversee the global VMS to ensure supplier qualification, risk assessment, and ongoing performance monitoring meet regulatory and business standards.
  • Develop metrics and dashboards to track and report on supplier quality performance.
  • Lead the global strategy and execution for the validation and lifecycle management of GxP-relevant computerized systems.
  • Ensure CSV activities are aligned with regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practices (e.g., GAMP 5).
  • Collaborate with IT and business stakeholders to ensure new and existing systems are validated, maintained, and decommissioned in a controlled and compliant manner.
  • Champion data integrity and system security across all validated systems.
Key Requirements
  • Bachelor's or Master's degree in Life Sciences, Pharmacy, IT or Engineering, or related discipline.
  • Minimum of 10 years' experience in pharmaceutical, medical device, or life sciences industries with at least 5 years in a computer system validation senior leadership role.
  • Deep understanding of QMS frameworks, GxP compliance, and international regulatory requirements (e.g., 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 computerized systems lifecycle management.
  • Demonstrated success leading cross-functional teams and managing complex global projects.
  • Excellent leadership, communication, and stakeholder engagement skills.
  • Experience working in a matrixed, multinational organization preferred.
Uniphar Background

Uniphar group is a rapidly expanding global healthcare services business with a strong heritage in Ireland. Since its IPO in 2019, the group has grown organically and through acquisitions, strengthening its international reach. With a workforce of close to 3,000 employees across Ireland, the United Kingdom, the Netherlands, Nordics, and the USA, Uniphar partners with pharma and medtech manufacturers to improve patient access to medicines. Uniphar provides outsourced and specialised services to clients, supported by relationships with 200+ pharmaco-medical manufacturers and cross-geography capabilities.

Culture at Uniphar

Ethics and integrity are core to Uniphar's culture. The organization values entrepreneurial, innovative, and collaborative approaches, with a strong problem-solving ethos. Diversity is embraced as the business grows domestically and internationally.

Seniority level
  • Director
Employment type
  • Full-time
Job function
  • Quality Assurance
Industries
  • Pharmaceutical Manufacturing

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