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