Hybrid Quality Manager – Commercial Products

Posted 3 days ago

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About the role

  • 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

Quality Manager – Commercial Products

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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