Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.
To support our growth, we’re now looking for a collaborative, driven and proactive Quality Manager. You will be managing a UK based team of four and take a leading role in upholding the highest standards of product quality and compliance. You’ll ensure that all Quality operations run seamlessly and meet the rigorous requirements of GxP regulations, Clinigen Quality Systems and global industry standards.
Key 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.
Key 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
Interested? we would love to hear from you, please apply today for immediate consideration.