Associate Director, QMS & Compliance
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Job 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 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
- Champion and embed Catalents 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.
- 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.
- 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.
- 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.
- 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 Catalents global network. Benefit from a subscription to LinkedIn Learning providing access to 10000 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 7000 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 . 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.
Required Experience:
Director
About Company
Providing CDMO services, delivery technologies and manufacturing solutions to develop pharmaceuticals, biologics and consumer health products.
