Quality Director Group Global Quality

Quality Director - Group Global Quality (12 Month Fixed Term, Maternity Cover, Full Time, CityWest)

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

Computer System Validation (CSV) Leadership

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 Part11, Annex11) and industry best practices (e.g., GAMP5). 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.

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.

Leadership & Stakeholder Engagement

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.

People and Team

Create a culture of excellence within the quality team. Manage and grow a team of quality experts who foster 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 programme (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: Bachelor's or Master's degree in Life Sciences, Pharmacy, IT, Engineering, or a related discipline. Minimum of 10 years' experience in pharmaceutical, medical device, or life sciences industries with at least 5 years in a senior computer system validation leadership role. Deep understanding of QMS frameworks, GxP compliance, and international regulatory requirements (e.g., FDA, EMA, HPRA, ISO13485, 21CFR Part11, GAMP5). 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 Requirements

• Minimum 10 years' experience in pharmaceutical, medical device, or life sciences industries.
• At least 5 years in a senior computer system validation leadership role.
• Deep understanding of QMS frameworks, GxP compliance, and international regulatory requirements.
• 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.