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.