Oversee operations and delivery of personalised care services in Cambridge, ensuring compliance with regulatory standards and effective team management.
About the role
- Quality Manager at Clinigen overseeing product quality and compliance. Leading a team and managing quality operations for pharmaceutical services in the UK.
Responsibilities
- Take ownership of Clinigen’s quality and technical activities as a global Marketing Authorisation Holder (MAH).
- Lead relationships with Contract Manufacturing Organisations (CMOs), distributors, and quality partners worldwide.
- Oversee quality investigations, including product complaints, deviations, CAPAs, and change controls.
- Manage key quality documentation such as Product Quality Reviews (PQRs), master batch records, and product files.
- Coordinate product stability programmes and support new product onboarding in collaboration with cross-functional teams.
- Plan and conduct GxP audits of CMOs, laboratories, and warehouses, ensuring supplier qualification and compliance.
- Support regulatory and quality system development, including internal audits and training.
- Act as a Quality ambassador, promoting GMP/GDP compliance, continuous improvement, and a culture of operational excellence.
- Ensure all Quality Technical Agreements are current and that product safety and compliance are maintained at all times.
- Prepare for and support audits (customer, supplier, and regulatory) while contributing to data analysis and continuous improvement initiatives.
- Take proactive ownership of your own professional development and stay informed on key compliance topics such as falsified medicines.
Requirements
- Life Science degree or equivalent.
- Substantial experience within the pharmaceutical industry
- Previous experience working directly for a Marketing Authorisation Holder is beneficial
- Previous experiences in managing relationships with Contract Manufacturing Organisations is beneficial
- A strong working knowledge of GMP and GDP, across dosage forms.
- Experience of regulatory inspections
- Proven ability of accurate and timely completion of tasks.
- Adaptable to changing situations, with a proactive positive, flexible, assertive, can do attitude
- Good influencing and stakeholder management skills
- Strong written and verbal communication skills
- Able to influence and lead by example, clearly communicating plans and results, promoting ownership and encouraging a collaborative approach to achieve solutions
- Able to delegate and prioritise effectively, considering individual and team strengths and development areas
- Ability to work with tight deadlines in a dynamic environment, delivering high quality outputs with strong attention to detail
- Previous experience as a line manager is beneficial
Benefits
- 27 days holiday plus bank holidays
- Discretionary Bonus Scheme
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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