Associate Director, QMS & Compliance

Catalent Pharma Solutions; Swindon; On-site; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Site performance bonus

Pension scheme 8% matching

Life assurance

Generous holiday entitlement

LinkedIn Learning access

Cycle to Work Scheme

Job summary

Catalent Pharma Solutions in Swindon is seeking an Associate Director, QMS & Compliance to lead the Quality Management System and ensure GMP/regulatory compliance.

You will build high-performing teams, drive continuous improvement, and oversee regulatory affairs, audits, and customer inspections, with onsite working 37.5h/week.

Qualifications

• Degree in pharmaceutical sciences or related field.
• Significant pharmaceutical industry experience with leadership and people management.
• Strong customer focus and stakeholder management with client-facing skills.
• Excellent problem-solving, risk management, and technical writing skills.
• Catalent leadership experience may be considered in lieu of external leadership experience.

Responsibilities

• Lead the Quality Management System (QMS) and ensure GMP compliance.
• Oversee regulatory affairs activities, including filings, DMF maintenance, and inquiries.
• Ensure site compliance with licences and quality/regulatory standards.
• Drive budget, resources, cost reduction, and continuous improvement programs.
• Develop, coach and lead the QA/QMS team with training and succession planning.

Skills

Quality Management

Regulatory affairs

Leadership

Continuous improvement

Team development

Education

Pharmaceutical Sciences

Chemistry

Physical Sciences

Related field

Job description

Position Summary

Our Swindon facility houses our Zydis® fast dissolving tablet development and manufacturing operation as well as a CMC pharmaceutical analytical lab services unit that offers ASAP stability.

We have an opportunity for an Associate Director, QMS & Compliance to join our team. In this role, you will lead all aspects of the Quality Management System and ensure compliance with regulatory and customer standards. You will manage quality systems, regulatory affairs, and drive continuous improvement initiatives. This is a key leadership position where you will develop high-performing teams and foster a culture of excellence and integrity.

Shift: Onsite Monday - Friday 37.5 per week. Location: Swindon, UK 100% Onsite

The Role

Champion and embed Catalent's values of Patient First, Customer Dedication, People, Innovation, Integrity, and Excellence. Lead and maintain the Quality Management System (QMS), ensuring compliance with GMP, FDA, MHRA, and other applicable regulatory requirements. Oversee regulatory affairs activities, including regulatory filings, DMF maintenance, and responses to customer and regulatory authority enquiries. Ensure site compliance with Manufacturer/Importer Authorisations, Wholesale Dealer Licences, and all relevant quality and regulatory standards. Drive operational excellence through effective management of QMS budgets, resources, cost reduction initiatives, and continuous improvement programs. Partner with customers, suppliers, and internal stakeholders to support quality, compliance, and business objectives. Develop, coach, and lead a high-performing team, ensuring effective training, succession planning, and a culture of continuous learning. Maintain the highest standards of ethics, safety, quality, and professional conduct while supporting broader business initiatives as required.

The Candidate Minimum Requirements

• Degree in Pharmaceutical Sciences, Chemistry, Physical Sciences, or a related field.
• Significant pharmaceutical industry experience with proven leadership and people management capability.
• Strong customer focus, stakeholder management, and client-facing skills, with a track record of exceeding expectations.
• Excellent problem-solving, risk management, change management, and technical writing skills.
• Demonstrated leadership at Catalent, including participation in leadership programmes, may be considered in lieu of external leadership experience.

Preferred Skills & Background

• Excellent communication and relationship-building skills.
• Hands-on, adaptable, and commercially minded.
• Strong stakeholder management and influencing capabilities.
• Proven ability to lead, motivate, and develop teams.
• Proactive, results-driven, and aligned to strategic objectives.
• Strong business acumen with a focus on operational and commercial success.

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 8% and life assurance.
• Enjoy a generous holiday entitlement that increases with tenure, with 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.
• 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.

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 [e-mail]. 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, 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.