At a Glance
- Tasks: Lead the Quality Management System and ensure compliance with industry standards.
- Company: Join Catalent, a global leader in drug development and delivery.
- Benefits: Competitive salary, bonuses, generous holiday entitlement, and career development opportunities.
- Other info: Dynamic work environment with a strong focus on ethics and continuous improvement.
- Why this job: Make a real impact in healthcare while developing high-performing teams.
- Qualifications: Degree in relevant sciences and significant pharmaceutical industry experience required.
The predicted salary is between 42750 - 52250 £ per year.
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.
Position Summary
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
- 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 Catalent’s global network.
Benefit from a subscription to Linked In 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.
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
Disability Accommodations@catalent. com .
This option is reserved for individuals who require accommodation due to a disability.
Information received will be processed by a U.
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.
Associate Director, QMS & Compliance in Swindon employer: Catalent
Catalent is an exceptional employer located in Swindon, UK, offering a dynamic work environment where innovation and excellence are at the forefront. With a strong commitment to employee growth, Catalent provides extensive training and development opportunities, fostering a culture of continuous improvement and collaboration among a diverse team of over 140 quality professionals. Join us to make a meaningful impact in the pharmaceutical industry while enjoying a supportive workplace that values integrity and dedication to patient care.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, QMS & Compliance in Swindon
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Catalent. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Catalent.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Catalent. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Catalent is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director, QMS & Compliance in Swindon
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Catalent!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Catalent that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Catalent!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Catalent, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Catalent
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Catalent that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Catalent’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
