Global QMS Manager - Corporate Quality

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives: The WEP Clinical Quality Systems Manager will lead the ongoing development and optimization of the Global Quality Management System (QMS), driving maturity, efficiency, and compliance across the organization. This role plays a key part in leveraging data to support continuous improvement and embedding a culture of operational excellence aligned with global regulatory standards such as ISO 9001, MHRA, FDA, and EMA. The Quality Systems Manager will also ensure the effective and compliant delivery of core quality functions including Training, Document Control, and Validation, while aligning these programs with broader business goals.

What You Can Expect: This exciting role will be crucial in project managing and delivering critical company Quality objectives, such as enhancement of the current eQMS and driving improvement in metrics and KPIs for quality monitoring activities.

The Long-term Vision For The Successful Candidate Is To Grow Within The Company, Building And Leading a Team, And To Become Pivotal Decision-maker In The Strategic Development Of WEP Clinical Quality Management System, Driving a Robust, Scalable Model Within The Company, In Addition To Continuing The Strong Quality Culture And Quality Compliance Levels At The Company.

What You\’ll Do:

• Shape and execute the strategic roadmap for the Global QMS, driving proactive, science-led, compliance-focused improvements.
• Own the project management of the eQMS to deliver a compliant, robust, and scalable platform for critical operations.
• Oversee Document Control, Training, and Validation across computer, facility, equipment, shippers, and other GxP systems.
• Simplify, harmonise, and digitalise QMS processes; lead cross-functional improvement initiatives from end to end.
• Lead and ensure timely closure of Deviations, CAPAs, Risk Assessments, and Change Controls for corporate and global processes.
• Track evolving global GxP regulations (FDA, EMA, ICH) and translate them into actionable policies and system updates.
• Define and monitor service-level metrics, and collaborate with stakeholders to enhance service line performance.
• Manage the Global QMS Training Program role-based curricula, competency assessment, and compliant, accessible records.
• Manage the Global Document Control System efficiently and compliantly, ensuring the creation, review/approval, distribution, archiving, and retrieval of GxP documents.
• Lead the Validation program for computerised and non-computerised systems; maintain a validated state per 21 CFR Part 11, Annexe 11, GAMP, GDP/GMP.
• Integrate quality subsystems (CAPA, Change Control, Training, etc.) to enhance efficiency, interoperability, and data integrity.
• Provide hands-on support for operational execution in training, document control, and validation when required.
• Recruit, mentor, and develop a high-performing Quality team; champion a strong quality culture and mindset.
• Drive compliance through metrics and data-driven decision-making to continuously improve the Global QMS.
• Partner with IT and process owners to deliver technology solutions that strengthen QMS effectiveness and business scalability.
• Establish and maintain a framework for monitoring QMS effectiveness using KPIs and KQMs; analyse trends to proactively mitigate risk.
• Prepare and present executive-level compliance reports and QMS performance reviews; ensure timely audit follow-up and CAPA effectiveness.

What You\’ll Need:

• Bachelor\’s Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 7+ years of related industry experience
• Previous managerial/leadership experience within pharmaceutical or life sciences industry
• Proven management and leadership capabilities.
• Proven experience of implementation and management of Quality Management Systems
• Expert understanding of Quality Management System processes (e.g., risk assessments, deviations, change control, supplier/customer management).
• Strong communication and interpersonal skills.
• Strong understanding of learning principles and effective GxP training methods.
• Understanding of validation lifecycles for equipment, shippers, facilities and utilize.
• Proficiency and understanding of CSV including validation lifecycle, risk-based approaches and compliance with 21 CFR Part 11/Annex 11 and GAMP.
• Strong analytical capabilities – able to interpret data effectively and make strategic decisions.
• Demonstrated ability to develop, implement and monitor meaningful quality metrics to assess QMS and service line performance and drive continuous improvement.
• Ability to utilize initiative, thinking pro-actively/solution-driven, balancing risk and business need effectively.
• Ability to take a risk-based approach with their day-to-day activities.
• Ability to be adaptable and prioritise effectively, working towards deadlines.
• Ability to assess and collaborate with others regarding the business needs and next steps for initiatives.

What We Offer: Private healthcare insurance Long-term illness Cover Death in service cover Salary sacrifice pension Annual leave Paid maternity & paternity leave Volunteer day

What Sets Us Apart: WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We\’re Committed to Our Team: WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.

We\’re Committed to DEI: At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth and to embracing everyone\’s unique identities.

Our services include: Access Programs Clinical Trial Services Patient Site Solutions Clinical Trial Supply Market Access and Commercialization

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.