Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Will work with hazardous/toxic materials Job Description Position Summery: We are seeking a dedicated, innovative person valuing Quality, with current expertise, passionate about enhancing QMS for cGMP compliance in Controlled Substances. In this role, you will play a crucial part in ensuring the safe and compliant management of controlled substances at our Swindon site. Every day could be different leading and supporting a range of activities including risk management, internal & external audits, training, change control, deviations and CAPA, supplier assurance, document lifecycle, and metrics reporting. As process owner for one or more of these processes, we want someone to drive the ownership and accountability for process compliance. This will require staying up to date with standard processes, corporate and regulatory requirements. A day in the life: Responsibility for controlled substance management for the site CSP. Collaborate with controlled substances regulators such as the Home Office. By leading internal audits, you will support site inspection readiness whilst collaborating sitewide to ensure key objectives are efficiently achieved. As a qualified trainer, share knowledge through structured training, particularly for controlled drug handling. Draft, review, and approve diverse documents such as procedures, deviations, CAPA, etc. Successfully employ electronic tools (e.g., Trackwise, eDMS, SFLMS) to assist site success in Quality systems and compliance duties. Apply innovative tools for extracting, analysing, and interpreting QMS data to support management reporting, propose solutions to any trends identified, and collaborate on resolutions. A proactive approach to problem-solving, meaningful assignments, and working to critical timelines is important to facilitate quality compliance. Provide inspiration, mentorship, and support to the team as a credible leader. Deputise for the Quality Compliance Manager when required, ensuring continuity and effective management of compliance duties. Education & Skills Relevant science-based degree; e.g., Chemistry, Biology, Pharmacy, or equivalent Approx. 7 years of relevant pharmaceutical/ biotech experience in a regulated environment (e.g., FDA, EU GMP, JP) Demonstrated experience in running audits/inspections of domestic regulators for controlled substances Qualified Lead Auditor Able to communicate well with all levels of the business Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.