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. As the Site Controlled Substance Program Lead, you will play a crucial role 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