Job Title: Senior Quality Director

Reports to: VP Quality, Pharma & Consumer Health

Location: Swindon, UK

Position Summary:

Lead and oversee the Swindon Campus Quality Department through Senior Quality Managers and Associate Directors, providing strategic direction and day-to-day management across all quality functions.

Hold full accountability for Quality Operations, spanning Quality Control, Quality Assurance, Regulatory Affairs, Validation, and GMP/Technical Training, ensuring each area operates to the highest standards.

Champion site-wide compliance with current Good Manufacturing Practice (cGMP) guidelines, Catalent Corporate Quality Policies, and applicable Catalent Pharma Solutions quality standards, embedding a culture of continuous improvement and regulatory excellence.

Build, develop, and inspire a high-performing Quality Management team of 140+ people, fostering professional growth through regular performance reviews, quarterly assessments, and ongoing development initiatives.

The Role:

• To promulgate, lead and live the Catalent Values: Patient first, Customer dedication, People, Innovation, Integrity, Excellence.

• To ensure the Quality function complies with Health, Safety and Environmental, and Security requirements and that employees adhere to the “Standards of Business Conduct”

• Individual is appointed as the management representative who, irrespective of other responsibilities, shall have established authority over and responsibility for:

• Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and

• Reporting on the performance of the quality system to management with executive responsibility for review.

• Responsible for all aspects of the Quality Assurance, Quality Control and the Quality Management System. Included in the functions are sampling testing (analytical and microbiological), and release of all products; administration of the stability program; primary contact with all regulatory agencies, to include, but no limited to FDA and MHRA; primary point of contact with all suppliers and customers on quality and regulatory issues.

• Responsible for regulatory affairs activities, including preparation and maintenance for DMF’s and responding to regulatory inquiries from customers and regulatory agencies.

• Responsible for Swindon campus compliance with legal requirements of the Manufacturers/Importers Authorization, Wholesale Dealer’s Licenses, customers MA’s/NDAs, and requirements of Good Manufacturing Practice.

• Responsible for ensuring the compliance aspects of controlled substances are managed in accordance with Home Office requirements

• To determine, establish and maintain comprehensive systems that establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer requirements.

• To approve client and supplier Quality Agreements on behalf of the reporting manager 

• To manage the Quality budget, Cost Reduction and Operational Excellence Programs within Quality

• To ensure that adequate resources are available for the function to meet its obligations.

• To act as a primary contact with Regulatory Agencies and for senior Quality professionals within our customers organizations.

• To liaise with other functions at Swindon and within the Catalent Pharma Solutions organization, on aspects of Quality and Compliance.

• To continually review the operation of the quality function on site, to provide best practice and deliver a program of continuous improvements to the methodologies/systems employed which will result in measurable operating benefits.

• As one of the senior managers on site, there will be an input into site management that will reinforce the site operation and as such the ability to participate in issues outside the job function is key, as is the ability to influence people outside of the direct sphere of control.

• To ensure that employees in Quality Operations are effectively trained according to cGMP principles, technology, site operating procedures and Catalent Quality policies.

• To develop strategic plans for resource and equipment requirements based on the strategic growth objectives for the business. 

• To demonstrate strong leadership skills to engage the team, motivating and coaching team members to achieve their potential whilst managing poor performers. To develop members within the team to provide a succession plan as recognized SMEs.

• To embed a culture (skills, capabilities & knowledge) which encourages self-development within the team. 

• To ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Catalent values. 

• To assist in other duties as required by Senior Managers, which are appropriate to the position

• Other duties as assigned

The Candidate:

• Education to degree level or higher in pharmaceutical sciences, chemistry, or physical sciences desirable 

• Significant experience in the pharmaceutical industry  

• Extensive management experience 

• Customer-related experience and excellent client facing skills. A desire to meet   and indeed exceed customers’ expectations 

• Strong problem solving, risk management, change management and technical writing

• Skills

• Experience of excellent stakeholder management and be to influence and gain support

• Strong ability to engage and motivate others 

• Proactive and able to work according to strategic direction 

• Target driven individual with high level of business acumen  

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.