Compliance and Quality Manager (RP)

Summary Working for a family run business. This is a great opportunity to be part of a fast-growing organisation, working within a friendly, supportive team. You will be responsible for keeping the business audit-ready, safe and well run as we grow from distributor to Marketing Authorisation holder. You are the named Responsible Person and qualified person on our licences, supported by two trained Deputy RPs. You also own health and safety, and handle the HR and facilities admin so the leadership team can focus on decisions. The company is in a very lovely rural setting therefore, candidates must be able to drive. This is a part-time opportunity and the chosen candidate will be required to work About 16 hours a week (equivalent to 2 days). Pattern agreed with the successful candidate, e.g. 4 mornings or 2 days Key duties and responsibilities Act as the named Responsible Person on the MHRA WDA(H) and the named qualified person on the VMD WDA(V) Maintain the GDP quality system: SOPs, supplier and customer approval, temperature control, returns, recalls, complaints, deviations and CAPA Own ISO 9001 and ISO 14001: internal audits, management review and external surveillance audits Lead MHRA and VMD inspections and close out findings on time Prepare the company to become a Marketing Authorisation holder: set up and oversee the outsourced QPPV and pharmacovigilance service, and act as the internal contact for regulatory affairs and the contract manufacturer Train and supervise ..... full job details .....