Manager, QMS and Compliance

Catalent

  • Swindon
  • Permanent
  • Full-time
  • 8 days ago
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) committed to helping people live better, healthier lives. We partner with pharmaceutical, biotech, and consumer health companies to support product development, launch, and full life-cycle supply. With over 40 global sites and thousands of scientists and technicians, Catalent delivers billions of doses of life-enhancing and life-saving treatments annually.Step into a leadership position within our Quality department, managing and driving excellence across the Quality Management System (QMS), Regulatory Affairs, Validation, and GMP/Technical Training. You’ll work closely with senior managers and cross-functional teams to ensure that operations meet both internal quality standards and external regulatory requirements.You’ll lead the QMS function across the Swindon site, supporting quarterly performance reviews and fostering a culture of continuous improvement aligned with Catalent’s core values: Patient First, Customer Dedication, People, Innovation, Integrity, Excellence.The Role:
  • Champion compliance with cGMP, Catalent Corporate Quality Policies, and applicable global standards.
  • Oversee the maintenance and management of regulatory filings (FDA, MHRA), liaising with suppliers and customers on QMS and regulatory matters.
  • Lead Regulatory Affairs including DMF documentation and responses to regulatory inquiries.
  • Ensure site compliance with all manufacturing licences and GMP practices.
  • Develop and maintain robust systems for documenting and monitoring quality standards.
  • Manage departmental budgets and support cost reduction and operational excellence initiatives.
  • Provide strategic direction on resource planning and validation equipment needs.
  • Collaborate with internal stakeholders on QMS and compliance projects across sites.
  • Deliver effective GMP, technical, and policy training to team members.
  • Drive a programme of continuous improvement and best practices within QMS methodologies.
  • Motivate, coach, and develop your team, building a strong succession pipeline of subject matter experts.
  • Uphold high ethical standards across all engagements and ensure quality is embedded in every process.
The Candidate:
  • Degree/higher qualification in pharmaceutical sciences, chemistry, or related field (preferred) OR equivalent technical knowledge.
  • Extensive experience in the pharmaceutical industry, particularly in QMS leadership.
  • Proven management experience and stakeholder influence.
  • Exceptional client-facing and communication skills.
  • Strong analytical abilities in risk, change, and problem management.
  • Skilled in technical writing and quality documentation.
  • Agile mindset with a hands-on, entrepreneurial approach.
  • Committed to personal development and continuous team growth.
Why You Should Join Catalent:
  • Competitive Salary – Reflecting your experience and skills.
  • Bonus & Benefits – Includes an annual performance bonus, a pension scheme matching up to 8% and life assurance. Enjoy BUPA private medical insurance, a generous holiday entitlement that increases with tenure, and the option to purchase additional leave. Plus, gain access to Reward Gateway, offering discounts at many national retailers.
  • 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. Take advantage of a Cycle to Work Scheme and an Electric Vehicle car scheme. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus, participate in charitable activities.
  • Excellent Location – Just a two-minute drive from J16 of the M4, 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 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 . 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.

Catalent