Qualified Person

Qualified Person (QP)

Position: 3 days a week (22.5 hours), hybrid with 2 days onsite, travel in UK & EU approximately once a month.

We’re looking for an experienced Qualified Person (QP) to provide QP certification, quality leadership, and compliance oversight across Crinone® commercial operations. You’ll ensure batches are released in line with UK legislation, cGMP, and the Orange Guide, while supporting projects, audits, and continuous improvement across the business.

• Certify commercial batches in accordance with UK legislation and product licences.
• Ensure all manufacturing meets cGMP and Orange Guide requirements.
• Provide Quality, compliance, and regulatory guidance to the Crinone Quality team.
• Review BMRs, deviations, and key PQS processes (Change Control, CAPA, QA agreements, etc.).
• Conduct internal/external GMP audits and support client/regulatory inspections.
• Oversee contractor and supplier performance through site visits and business reviews.
• Contribute to Product Quality Reviews and manage any Product Recalls.
• Support materials management, risk assessments, and QA leadership activities.
• Lead CI projects and ensure safe working practices.

• Eligible to act as a QP with a science‑based degree.
• Strong understanding of GMP Quality Systems for pharmaceutical manufacturing.
• Knowledge of EU/US GMP, ICH, and WHO guidance.
• Trained auditor with experience in client and regulatory inspections.
• Excellent communication, organisation, and stakeholder management skills.
• Proficient in Microsoft Office and able to work effectively under pressure.

• Competitive Salary – Reflecting your experience and skills.
• Bonus & Benefits – Includes a site performance bonus, a pension scheme matching up to 6 % and 4 × life assurance. Enjoy private medical insurance, a generous holiday entitlement that increases with tenure, and the option to buy leave.
• Career Development – Access high‑quality training, mentoring, and cross‑functional opportunities within Catalent’s global network. Benefit from a subscription to Linked In Learning, providing access to 10,000+ online courses.
• Health & Wellbeing – Includes an employee assistance programme, on‑site canteen facilities, and an active safety and Patient First culture. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus, participate in charitable activities.
• Excellent Location – Just a few minutes’ drive from J26 of the M1, with free on‑site parking. Commutable from Derbyshire, Leicestershire, and Nottinghamshire.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to Disabili This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration to the application or hiring process.

Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Thank you.