Job Description

Position: Global Quality Team Leader (Systems)

Department/Function: Global Quality – Electronic Quality Systems

Reports to: Global Quality Systems Manager

Direct Reports: Quality Specialist (Systems); Senior Quality Specialist (Systems)

Role Objective

Lead a multi‑site team of Quality Systems professionals to provide, maintain and continuously improve global electronic quality systems and solutions, ensuring compliance with internal standards and applicable regulations.

Key Responsibilities

1. Team Leadership & Mentoring
2. Guide and develop Specialists/Senior Specialists to ensure effective development, implementation and maintenance of electronic quality systems in line with regulatory and internal requirements.
3. Planning & Resource Management
4. Coordinate team activities, plan resources against business/project needs, generate work estimates and commit to realistic delivery timelines.
5. Performance & Escalation Management
6. Monitor team and personal progress, report status and risks to the Global Quality Systems Manager, and promptly escalate issues impacting quality or timelines.
7. Audit & Inspection Support
8. Support local site QA during client audits and regulatory inspections as required.
9. Stakeholder Collaboration
10. Collaborate with cross‑functional stakeholders to gather, clarify and document precise business and technical requirements.
11. Design & Decision Support
12. Support system design decisions and issue resolution; prepare materials to secure wider business and quality approvals when needed.
13. Operational Support & Service
14. Manage and respond to queries/requests to provide timely, effective support for electronic quality system issues and enhancements.
15. Lifecycle Documentation
16. Develop, review and approve computerised system lifecycle documentation to establish and maintain compliant systems aligned to company requirements, regulations and industry best practice.
17. Change Management
18. Facilitate all aspects of Quality System change control, including preparation and review of computerised system change documentation.
19. People Management
20. Support recruitment, onboarding and training of new team members; deliver ongoing training and development.
21. Performance Management
22. Conduct annual performance appraisals and regular check‑ins.
23. Metrics & KPIs
24. Monitor adherence to Quality metrics/KPIs and drive corrective and preventive actions as needed.
25. Project Delivery
26. Take actions necessary to ensure successful delivery of Quality System projects across all global sites.

General Responsibilities

• GxP Compliance: Ensure GMP is adhered to in all areas of work and champion a quality‑excellence mindset that assures safe and efficacious product for patients.
• PQMS Engagement: Complete and proactively manage quality records in accordance with timelines; contribute to continuous improvement of the Pharmaceutical Quality System.
• Health, Safety & Environment: Follow company HSE procedures and report accidents/unsafe conditions.
• Training & Development: Complete required training before performing duties; ensure training is current and recorded.
• HR Policies: Adhere to HR policies, including absence procedures.
• Communication: Share relevant information within the department; provide regular updates to line management on projects and responsibilities.
• Equal Opportunities: Support a neutral and respectful work environment free from bullying/harassment.
• Core Competencies: Execute responsibilities in accordance with the company’s core competency framework.

Person Specification

Position: Global Quality Team Leader (Systems)

Reports to: Global Quality Systems Manager

Direct Reports: Quality Specialist (Systems); Senior Quality Specialist (Systems)

Qualifications

• Essential: Bachelor’s degree in a Scientific or Technical discipline or significant relevant experience in a comparable technical role.
• Desirable: Bachelor’s degree (or equivalent) in Computer Science or related discipline.

Experience

• Essential:
• Significant experience working within an established Quality System in the pharmaceutical industry.
• Demonstrated collaboration with cross‑functional teams and stakeholders at all organisational levels as part of project teams.
• Line management/people leadership experience.
• Desirable:
• ~2 years’ supervisory experience.
• Experience contributing to design and/or implementation of enterprise‑level computer systems.
• Working knowledge of Computer Systems Validation (CSV).
• Experience in testing of computerised systems.

Key Skills & Knowledge

• Essential:
• Ability to map and optimise processes using appropriate software tools.
• Excellent communication skills (verbal, written, listening).
• Strong organisation, planning and prioritisation in high‑volume, varied workloads.
• High attention to detail under pressure.
• Proven leadership skills with a track record of managing and developing high‑performing teams.
• Desirable:
• Knowledge of global regulations and guidance relevant to quality systems and CSV (e.g., FDA, EMA, ICH).
• Strong problem‑solving and analytical ability.

Core Competencies (Company Framework)

• Results Delivery: Delivers on time within constraints; drives quality and excellence.
• Proactive Solutions: Uses experience and logic to make sound decisions; seeks practical and innovative methods.
• Leads by Example: Promotes a clear mission; role‑models teamwork and development.
• Communication: Communicates clearly and transparently; fosters effective information flow.
• Customer Focus: Exceeds expectations of internal/external customers; values high‑quality service.
• Job‑Specific Knowledge: Demonstrates and develops role‑specific knowledge; follows SOPs and correct procedures.