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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.
The Ideal Candidate:
- Analytical
- Collaborative
- Adaptable
- Proactive
What You'll Do:
- Contribute to the strategic development and continuous improvement of the Global Quality Management System (QMS).
- Oversee and optimize Document Control, Training, and Validation processes across GxP systems.
- Identify and lead QMS simplification, harmonization, and digitalization initiatives.
- Stay current on global GxP regulations and translate changes into actionable improvements.
- Manage the global training program to ensure compliance, competency, and complete training records.
- Manage document control to ensure efficient, compliant handling of GxP-controlled documents.
- Lead the validation program across all systems, ensuring compliance with regulatory requirements.
- Ensure integration and interoperability of quality system elements to enhance efficiency and data integrity.
- Lead and mentor a high-performing team, fostering a culture of quality and continuous improvement.
- Develop and monitor QMS KPIs and metrics to drive data-driven decisions and risk mitigation.
What You'll Need:
- Bachelor’s degree or higher, preferably in pharmaceutical sciences, life sciences, or engineering
- 7+ years of relevant industry experience, including leadership in a pharmaceutical or life sciences setting
- Proven experience implementing and managing Quality Management Systems
- Strong understanding of QMS processes such as risk assessments, deviations, change control, and supplier/customer management
- Experience with GxP training programs and validation lifecycles (equipment, facilities, shippers, etc.)
- Proficiency in Computer System Validation (CSV), including 21 CFR Part 11, Annex 11, and GAMP
- Demonstrated ability to develop and monitor quality metrics to drive performance and continuous improvement
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.
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