Disclaimer: Hunt UK Visa Sponsors aggregates job listings from publicly available sources, such as search engines, to assist with your job hunting. We do not claim affiliation with Mundipharma. For the most up-to-date job details, please visit the official website by clicking "Apply Now."
OMQ-M4-14
Head of EU Quality
Location: Cambridge
Department: Global Quality Network and Product Supply
Job type: Permanent
Join us and make a difference when it matters most!
At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
Role And Responsibilities
- To effectively lead the EU regional quality team of Responsible Persons by direct management of the cluster Leads
- To provide quality guidance to all IACS within the EU region
- Implement and maintain systems within the EU IACs to facilitate metrics, training, management review and reporting.
- Provide Leadership and strategic direction for the Mundipharma EU region; contribute effectively inthe corresponding LT
- Oversee the maintenance and development of the Quality Management System (QMS) for the Mundipharma UK entities, in compliance with applicable regulations
- Acting as a Responsible Person and RPi for the Mundipharma UK entities
- Act as a Qualified Person for GMP for the Bard manufacturing facility if qualified
- At global level, advise on the global QMS on behalf of all IACs
- Sit on the extended Quality leadership team
Technical
Leads, prepares and/or delivers effective QM-related training to the EU/UK IACs and/or Global network of IACs
- Supports the management of inspections by regulatory bodies as needed across the EU IAC network and conducts inspection readiness audits, developing remediation plans as needed in conjunction with the IAC management teams.
- Applies effective leadership principles to achieve both functional and business objectives, providing direct oversight and guidance to the business in the area of Quality Management Systems.
- Ensures systems are established to maintain visibility and awareness of changes in legislation, guidelines and pharmacopoeias, recommending areas for action and implementing change as required.
People
- Coach and develop the direct reporting team to ensure they have the appropriate skills and knowledge to drive the business forward.
- Commit to personal development and training for individual and team needs, ensuring development plans and annual reviews are in place for each individual.
- Work in a team spirit to further drive the function and business needs.
- Work closely with other functions (e.g. Supply Chain, NPI, External Warehouses, Internal Customers, Scientific Affairs etc.) to ensure product can be compliantly distributed to market in support of market demand.
- Ensure business compliance with statutory duties, regulations and legislation. Ensure activities meet with and integrate with organisational requirements for quality management, health and safety, legal, Code of Business Ethics, environmental policies and general duty of care.
- Create, develop and support the process of continuous improvement with the aim to reduce cost, improve quality and increase efficiency.
Global QMS Leadership
- Advise on the global QMS to ensure this is developed and maintained to serve the IAC network
- Create, revise and maintain up to date global and local policies and Standard Operating Procedures (SOPs), ensuring all relevant employees are trained accordingly.
- Lead or contribute to global and functional projects as required.
Designations
- Acting as a Responsible Person and RPi for the Mundipharma UK entities
- Act as a GMP Qualified Person for the UK manufacturing facility, when necessary and if qualified
- Act as Management Representative for the Mundipharma GmbH Legal Manufacturer of betadine advanced wound gel
Quality Leadership
- Sit on the extended Global Quality Leadership team (QLT), providing input to strategic decision making and cascading information, global objectives and key messages to the EU Quality team
What You’ll Bring
- Degree in Pharmacy, Chemistry or related discipline
- Existing Import and Wholesale License Holder for Drugs, Devices and Controlled Drugs (Poisons) Certifications or Designations
- Responsible Person for GDP
- Qualified Person for GMP
- Detailed experience in a QA role, particularly in managing pharmaceutical Quality Systems.
- Managing outsourced activities and third party service providers
- Developing Teams
- Hosting of GxP inspections
- Supervisory experience in motivating teams, managing performance and coordinating the workload of others
- Experience in acting as an RP / RPi
- Experience of QP batch release
- Working in an international setting
- Working with controlled medicines
- Competent Auditor
- Proficient in the use of Microsoft Office applications
- Excellent knowledge in National and International Pharmaceutical Legislation.
- Proactive, pragmatic, independent, organized and self-confident.
- Leadership and motivation skills
- Customer focused and cross-functional thinking and behaviour.
- Works collaboratively maintaining good working relationships with cross functional teams and partners actively participating contributing to team success.
What We Offer In Return
- Flexible benefits package
- Opportunities for learning & development through our varied programme
- Collaborative, inclusive work environment
Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.
About Mundipharma
Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.
Join our talent pool
If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.
Additional Job Description:
Primary Location:
GB Cambridge
Job Posting Date:
2025-07-07
Job Type:
Permanent
