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.

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