Director of Quality Assurance & Regulatory Affairs (QA/RA)Director of Quality Assurance & Regulatory Affairs (QA/RA)Stoke on Trent, StaffordshireFull TimeShare jobLocation: Head Office in Stoke on TrentReports to: Managing DirectorDepartment: Quality & Regulatory AffairsNVS is a leading provider of veterinary pharmaceutical products throughout the UK, with annual revenues exceeding £600 million. The company is now looking to leverage its experience and infrastructure to launch a new division specialising in the storage and distribution of human pharmaceuticals, controlled drugs, and medical devices. We are seeking a highly experienced Director of Quality Assurance & Regulatory Affairs (QA/RA) to lead all aspects of our quality and regulatory compliance functions.This senior leadership role will ensure NVS operates to the highest standards of Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and all relevant MHRA, Home Office, and ISO requirements.The successful candidate will maintain oversight of all regulatory licences, quality systems, and compliance processes, ensuring our operations meet the exacting standards expected within the UK’s human pharma and medical device logistics sectors.A background as a Qualified Person (QP) would be advantageous, but not essential.Lead, maintain, and continuously improve the company’s Quality Management System (QMS) to ensure compliance with:GDP and GMPISO 9001:2015, ISO 13485:2016, and ISO 15378 (where applicable)MHRA and Home Office regulations governing the storage, handling, and transport of pharmaceuticals and controlled drugsEnsure all activities relating to controlled drugs (CDs) fully comply with the Misuse of Drugs Act 1971, Misuse of Drugs Regulations 2001, and relevant Home Office licensing conditions.Maintain oversight of the company’s WDA(H) (Wholesale Distribution Authorisation – Human) and Controlled Drug Licence(s), ensuring ongoing compliance and readiness for inspection.Lead internal and external audit programmes, ensuring findings are closed effectively and used to drive improvement.Oversee all quality events including deviations, product quality complaints, CAPAs, change controls, and recalls, ensuring timely investigation and escalation as needed.Ensure robust temperature monitoring, validation, and qualification programmes across the supply chain, including storage and transportation activities.Regulatory Affairs OversightAct as the company’s lead contact for MHRA, VMD, and Home Office, ensuring open, professional, and proactive communication with all regulators.Ensure all company licences, authorisations, and registrations remain current and compliant.Manage the submission of applications, renewals, and variations for regulatory licences, including WDA(H), GMP, and Home Office Controlled Drug Licences.Oversee regulatory due diligence for new customers, service lines, and facilities to ensure compliance from design to delivery.Provide regulatory interpretation and advice to senior management, ensuring business decisions align with the latest legislative requirements.Stay informed of changes to UK and EU legislation, guidance, and best practice affecting pharmaceuticals, controlled drugs, and medical devices, and advise the business accordingly.Work with our clients in relation to all Technical AgreementsControlled Drugs & Home Office ComplianceEnsure all handling, storage, and distribution of controlled drugs complies fully with Home Office regulations, including safe custody, record keeping, security, and destruction requirements.Maintain robust systems for CD reconciliation, traceability, and incident management.Liaise directly with the Home Office Drugs and Firearms Licensing Unit (DFLU) and relevant authorities during inspections or investigations.Provide internal training and guidance on controlled drug regulations and best practice.Ensure clear segregation and risk management of Schedule 2, 3, 4, and 5 controlled substances as defined under UK law.Lead and inspire the Quality and Regulatory Affairs teams, fostering a culture of accountability, integrity, and continuous improvement.Mentor and develop team members to strengthen capability across GDP, GMP, and regulatory disciplines.Collaborate effectively with Operations, Commercial, and Customer Service teams to ensure quality and compliance are integrated into all business processes.Deliver business-wide training and awareness programmes on GDP, GMP, and controlled drug compliance.Continuous Improvement & Risk ManagementDrive continuous improvement in quality systems, documentation, and processes.Use quality metrics and trend analysis to identify emerging risks and prioritise mitigation actions.Ensure all quality KPIs and compliance indicators are reported regularly to the Executive Leadership Team and Board.Support new initiatives and transformation programmes by ensuring quality and compliance are built into the design and execution phases.Stakeholder EngagementRepresent NVS in all external audits and inspections conducted by MHRA, Home Office, or customers.Lead preparations for inspection readiness and manage post-inspection responses and action plans.Build and maintain strong relationships with customers, suppliers, and regulatory bodies to reinforce NVS’s reputation for excellence and trust.Advise the Managing Director and Board on compliance risks, emerging regulations, and strategic opportunities.Experience & QualificationsMinimum of 10 years’ experience in Quality Assurance and Regulatory Affairs within the pharmaceutical logistics, wholesale distribution, or medical device sectors.Extensive knowledge of GDP, GMP, MHRA, and Home Office compliance frameworks.Proven experience managing WDA(H) and Controlled Drug Licences and successfully leading MHRA and Home Office inspections.Strong familiarity with ISO 9001, ISO 13485, and ISO 15378 standards.Degree in Life Sciences, Pharmacy, Chemistry, or a related field.QP (Qualified Person) status or eligibility would be a significant advantage.Demonstrated leadership experience with the ability to influence and engage across all levels of the organisation.Exceptional communication and analytical skills with a hands-on approach to operational compliance.Experience with cold chain and temperature-controlled distribution.Strong understanding of medical device regulation (UK MDR 2002) and post‑market surveillance requirements.Commercial awareness, able to balance compliance with operational and customer needs.Confident communicator with the ability to represent NVS externally with regulators and clients.Why Join NVSThis is a pivotal leadership opportunity in one of the UK’s most respected healthcare logistics businesses. You will have the autonomy to shape our quality and regulatory strategy, lead critical compliance initiatives, and play a key role in ensuring NVS continues to deliver safe, compliant, and trusted services to the UK healthcare system.We offer a competitive salary, as well as a comprehensive benefits package, which includes:Annual Bonus SchemeLTIP25 days Holiday + 8 Bank Holidays, increasing with Length of Service #J-18808-Ljbffr