Quality Manager - Commercial Products

Clinigen; Burton upon Trent; On-site; GBP 45,000 - 65,000; Full time

Job summary

A rapidly growing specialty pharmaceutical company in the UK is seeking a Quality Manager to lead a team and ensure adherence to product quality and compliance standards. The ideal candidate will have a Life Science degree, extensive experience in the pharmaceutical industry, and a strong understanding of GxP regulations. This position includes managing quality documentation, conducting audits, and promoting GMP/GDP compliance. The company offers a comprehensive benefits package including 27 days holiday and pension contributions.

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

Qualifications

• Extensive experience in the pharmaceutical industry is crucial.
• Adaptability in changing situations with a proactive approach is required.
• Ability to work under tight deadlines while maintaining high-quality outputs.

Responsibilities

• Manage quality and technical activities as a global Marketing Authorisation Holder.
• Lead relationships with Contract Manufacturing Organisations and quality partners.
• Oversee quality investigations and manage key quality documentation.

Skills

Life Science knowledge

GMP and GDP knowledge

Leadership and communication skills

Stakeholder management skills

Attention to detail

Education

Life Science degree or equivalent

Job description

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.

Qualifications:

• 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.