Quality Director Group Global Quality

Uniphar Group; Ireland; On-site; EUR 160,000 - 210,000; Full time

Job summary

Uniphar Group is seeking a Quality Director for Group Global Quality at CityWest, Ireland. The role focuses on developing and harmonising a robust global quality framework across GMP sites, ensuring compliance with GxP and regulatory standards.

You will drive continuous improvement, risk-based quality controls, and strategic governance across the organisation. Reporting to the Technical Operations Director, you will lead global QMS, VMS, and quality processes, mentor teams, and build

Qualifications

• Bachelor's or Master's in Life Sciences, Pharmacy, IT or Engineering, or related field.
• 10+ years in pharma/medical devices with >=5 years in senior leadership CSV.
• Deep understanding of QMS, GxP, and global regulatory requirements (FDA/EMA/ISO).
• Proven vendor management, supplier quality, and audit oversight experience.
• Strong leadership, communication and stakeholder engagement in multinational teams.
• Fluent English; other European languages desirable.

Responsibilities

• Lead the design and continuous improvement of Uniphar's Global QMS.
• Ensure local systems align with global policies and procedures.
• Oversee VMS governance, supplier qualification, risk, and performance monitoring.
• Drive regulatory readiness and support internal and external audits.
• Mentor quality teams and lead cross-functional governance forums.

Skills

Leadership

Stakeholder engagement

Cross-functional collaboration

Quality management

Regulatory awareness

Education

Bachelor's or Master's degree in Life Sciences, Pharmacy, IT or Engineering, or related discipline

Tools

VMS platforms

QMS platforms

CSV tooling

Job description

Quality Director - Group Global Quality
12-Month Fixed Term (Maternity Cover)

Full Time

CityWest

Role Summary

Uniphar is recruiting for a dynamic and strategically minded Director of Group Global Quality to lead the development, governance, and ongoing enhancement of the company's Global Quality environment. This role will also be responsible for defining and implementing the Uniphar Group's quality management controls through harmonization applying a risk-based approach to quality management. This role will also be responsible for further enhancement and continuous improvement and efficiency projects within the company's GMP manufacturing sites.

This role is critical to ensuring that Uniphar maintains the highest standards of quality, compliance, and operational excellence across all geographies and business divisions.

Reporting to Technical Operations Director this role will define and implement a harmonised global strategy for quality management ensuring consistency, scalability, and compliance with all relevant regulatory requirements and industry standards. The role will provide leadership and subject matter expertise to global and regional quality teams, while driving integration across the quality function.

Key Accountabilities

Quality Management System (QMS) Oversight

• 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).

Vendor Management System (VMS) Governance

• 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.

Global Quality Strategy & Compliance

• 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.

Process Efficiency and Continuous improvements Projects

• Champion a continuous improvement mindset to improve efficiency while maintaining the highest regulatory standards across the group GMP sites.
• Review and streamline processes by enabling technology solutions

Leadership & Stakeholder Engagement

• Provide strategic and operational leadership to global and regional teams responsible for QMS, VMS, and GMP processes
• 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.

People and Team

• Create a culture of excellence within the quality team
• Manage and grow a team of quality experts who can fostering a culture of collaboration, and accountability.

Key Outcomes

• Successful roll out and adoption of Global QMS and Gate keeper tool across all Uniphar Entities
• Design and deliver a quality audit program (Internal and external)
• Development of a cross geographical quality team
• Harmonization of Quality Management Procedures across all Uniphar entities
• Embed a One Uniphar Quality Culture across all Uniphar entities

Candidate Profile

Experience

• 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.
• Fluent in English; additional European languages highly desirable.

Key Skills & Experiences

• Enjoy working in an entrepreneurial culture that moves quickly and requires rapid responses
• Comfortable networking and building business relationships