Director of Quality System
- Ireland
- Permanent
- Full-time
- 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 Gate Keeper Global Vendor Management System
- 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.
- Define and implement global strategies for quality systems that support compliance, scalability, and business efficiency.
- Stay current with regulatory trends and evolving quality requirements; proactively update global systems and processes as needed.
- Support internal and external audits and regulatory inspections by ensuring readiness and consistency across global operations.
- Provide strategic and operational leadership to global and regional teams responsible for QMS, VMS, and CSV.
- Build strong 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.
- Act as a member of the Global Quality Leadership Team.
- 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 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.