Are you an experienced Qualified Person with a background in sterile and biological products? Catalent, a global leader in contract development and manufacturing, is seeking a permanent Qualified Person (QP) to join our Clinical Supply Services team in Bathgate, Scotland.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

As the QP at our Bathgate facility, you will play a critical role in ensuring the quality and compliance of clinical supplies. You will act as the Qualified Person for the site, providing expert QA oversight and certification of finished products for clinical studies.

The Role:

• Certify finished products prior to release for clinical trials.
• Review and approve GMP documentation, including deviations and batch records.
• Liaise with internal and client quality teams to support batch release and continuous improvement.
• Participate in product recall investigations and regulatory compliance activities.
• Fulfil QP duties as outlined in Directives SI 2012/1916 and SI 2004/1031.
• Drive quality improvements in a compliant and controlled manner.

The Candidate:

• Qualified Person under SI 2012/1916 and/or SI 2004/1031.
• Experience with sterile and biological products; ATMP experience is a plus.
• BSc or equivalent in a relevant scientific discipline (e.g., Chemistry, Biology).
• Strong knowledge of GMP regulations and quality systems.
• Excellent communication skills and attention to detail.
• Ability to work cross-functionally and make decisive quality decisions.

Why You Should Join Catalent:

• Competitive Salary – Reflecting your experience and skills.
• Bonus & Benefits – Includes a site performance bonus, a pension scheme matching up to 7.5% and life assurance. Enjoy BUPA private medical insurance, a generous holiday entitlement that increases with tenure, and the option to trade leave.
• Career Development – Access high-quality training, mentoring, and cross-functional opportunities within Catalent’s global network. Benefit from a subscription to LinkedIn 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 J3A of the M8, with free on-site parking.

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. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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 [email protected]. 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 in 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.