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- Tasks: Lead the development of a Global Quality Management System and ensure compliance with regulations.
- Company: WEP Clinical is dedicated to advancing clinical research and transforming lives globally.
- Benefits: Enjoy private healthcare, long-term illness cover, paid leave, and a supportive work environment.
- Why this job: Join a mission-driven team that values innovation, collaboration, and making a real difference.
- Qualifications: Bachelor’s degree and 7+ years in pharmaceutical or life sciences with QMS experience required.
- Other info: WEP Clinical promotes wellness, growth, and diversity in a smoke-free, drug-free workplace.
The predicted salary is between 43200 - 72000 £ per year.
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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Global QMS Manager - Corporate Quality employer: WEP Clinical
Contact Detail:
WEP Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global QMS Manager - Corporate Quality
✨Tip Number 1
Familiarise yourself with the latest global GxP regulations and standards such as ISO 9001, MHRA, FDA, and EMA. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during discussions.
✨Tip Number 2
Network with professionals in the pharmaceutical and life sciences sectors. Attend industry conferences or webinars where you can meet people who work in quality management systems. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've implemented or improved Quality Management Systems in your previous roles. Highlighting your analytical and proactive approach will resonate well with the hiring team.
✨Tip Number 4
Showcase your leadership skills by discussing any experience you have in mentoring teams or leading projects. WEP Clinical values collaboration and a culture of continuous improvement, so demonstrating your ability to foster these qualities will set you apart.
We think you need these skills to ace Global QMS Manager - Corporate Quality
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Management Systems, particularly in the pharmaceutical or life sciences sectors. Emphasise your leadership roles and any specific achievements related to QMS processes.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality management and how your skills align with WEP Clinical's mission. Mention specific examples of how you've contributed to QMS improvements in previous roles.
Highlight Relevant Skills: Clearly outline your analytical, collaborative, and proactive skills in both your CV and cover letter. Provide examples of how these traits have helped you succeed in past positions, especially in managing teams or projects.
Showcase Continuous Improvement Initiatives: Discuss any initiatives you've led that resulted in process optimisation or compliance enhancements. This could include training programmes, document control improvements, or successful validation projects.
How to prepare for a job interview at WEP Clinical
✨Understand the QMS Landscape
Familiarise yourself with the key components of Quality Management Systems, especially in the context of pharmaceutical and life sciences. Be prepared to discuss your experience with ISO 9001, MHRA, FDA, and EMA regulations, as well as how you've implemented QMS processes in previous roles.
✨Showcase Your Analytical Skills
As the role requires a strong analytical mindset, be ready to provide examples of how you've used data to drive continuous improvement. Discuss specific metrics or KPIs you've developed and how they contributed to operational excellence in your past positions.
✨Demonstrate Collaborative Spirit
WEP Clinical values collaboration, so highlight instances where you've worked effectively within a team. Share experiences that showcase your ability to lead and mentor others while fostering a culture of quality and continuous improvement.
✨Stay Current on GxP Regulations
Research the latest trends and changes in global GxP regulations. Be prepared to discuss how you would translate these changes into actionable improvements for the organisation, demonstrating your proactive approach to compliance and quality management.
