Senior Quality Director

Position: Senior Quality Director

Location: Swindon, UK

Position Summary:

• To provide leadership and daily management of the Swindon Campus Quality Department though the Senior Quality Managers, and Associate Directors.
• To be accountable and responsible for managing all aspects of Quality Operations, including Quality Control, Quality Assurance, Regulatory Affairs, Validation, and GMP/Technical training.
• Responsible for ensuring the site is following cGMP guidelines, adherence to Catalent Corporate Quality Policies and applicable Catalent Pharma Solutions quality standards across the business.
• To manage and develop the Swindon Quality Management team (120+ personnel), including quarterly performance reviews and assessments.

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:
• 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 Authorisation, Wholesale Dealer’s Licences, customers MA’s/NDA’s, and with requirements of Good Manufacturing Practice
• 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.

Why you should join Catalent:

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
• Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions.
• Paid Time Off Programs incl. vacation, banked time & personal time.
• Employee Reward & Recognition programs.
• Opportunities for professional and personal development & growth including tuition reimbursement

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 DisabilityAccommodations@catalent.com. 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.