Catalent Pharma Solutions
Senior QA Associate - Quality Commercial Operations
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Senior QA Associate – Quality Commercial Operations
Location: Swindon
Job Summary
- 2 X positions open
- Monday - Friday 37.5 P/W Onsite
- Closing date: 30/06/26
The Senior QA Associate, Quality Commercial Operations, plays a key role in managing customer-facing Quality activities, acting as the main point of contact for assigned clients. The position ensures all Quality communications, commitments, and deliverables are handled in a timely, compliant, and professional manner. This role is integral to maintaining strong customer relationships, supporting batch release processes, and ensuring adherence to GMP and regulatory requirements, while driving continuous improvement across Quality systems and operations.
The Role
- Act as the primary Quality contact for assigned customers, managing all Quality-related communications
- Ensure accurate, timely, and professional responses to customer queries and requests
- Lead and coordinate customer audits, meetings, and visits (onsite and remote)
- Manage deviation notifications, ensuring effective communication and timely closure of actions
- Maintain oversight of all customer-related activities, driving actions through to completion
- Support batch release activities, including pre-release review of batch documentation (EBRs and paper records)
- Assist in the preparation, review, and maintenance of Quality Agreements
- Collaborate with cross-functional teams (Operations, QC, QMS, etc.) to support customer requirements
- Support customer and regulatory inspections as a subject matter expert
- Review and approve QA documentation including SOPs, Change Controls, and PQRs
- Monitor and report on customer metrics, escalating risks or concerns as needed
- Build and maintain strong relationships with both internal stakeholders and customer representatives
- Ensure all activities are conducted in line with GMP, regulatory requirements, and company standards
- Contribute to continuous improvement initiatives, including deviation reduction and right-first-time performance
- Support EHS&S initiatives and promote a strong safety and compliance culture
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The Candidate
- Proven experience within a pharmaceutical GMP environment, with strong knowledge of Quality Assurance
- Demonstrated understanding of Quality Systems and Data Integrity requirements
- Experience managing customer interactions, audits, and Quality-related communications (desirable)
- Strong problem-solving and analytical skills with excellent attention to detail
- Experience reviewing and approving QA documentation (SOPs, Change Controls, PQRs, investigations)
- Experience supporting batch release activities and reviewing batch documentation
- Confident working cross-functionally with Operations, QC, and other departments
- Excellent communication and stakeholder management skills
- Proficient in Microsoft Office and Quality-related electronic systems
- Highly organised with the ability to manage multiple priorities and meet tight deadlines
- Proactive, self-motivated, and able to work independently
- Team player with the ability to influence and build effective working relationships
- Continuous improvement mindset with experience in RCA, CAPA, and lean methodologies
Catalent
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 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.
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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.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
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