Compliance & 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 they grow from distributor to Marketing Authorisation holder. You are the named Responsible Person and qualified person on licenses, 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). Working pattern will be agreed with the successful candidate, e.g. 4 mornings or 2 days.
Key duties & 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 the Deputy RPs, and deliver GDP and quality training
• Own the H&S management system: risk assessments (warehouse, servicing, project installs and wall fixing), the accident book and incident investigations
• Fire safety: fire risk assessment, alarm and extinguisher checks, drills, fire marshals
• First aid cover, statutory checks (e.g. PAT testing, racking inspections) and H&S training for staff
• Recruitment support: screening CVs, scheduling interviews, right-to-work checks and preparing offer paperwork for sign-off (typically fewer than 5 hires a year)
• New starter inductions, and keeping the training and competency matrix up to date
• Keeping the staff handbook and HR policies under document control
• Booking and coordinating contractors, and keeping the maintenance log - Pest Control etc
• Tracking building safety certificates (electrical, gas, fire) and contract renewals (waste, utilities, cleaning)
• Monthly reporting to the COO on compliance status, open CAPAs, audits and H&S

Required qualifications, knowledge, experience & skills

• At least 3 years as RP or deputy RP on a WDA(H), with experience of MHRA inspections
• Experience running an ISO 9001 quality management system; ISO 14001 an advantage
• Cogent Gold Standard RP training or equivalent
• Able to work independently and keep good records while on site part-time
• Organised and discreet: handles confidential HR information appropriately

Only suitable candidates will be directly contacted about this position, and we will not store or process the data of candidates in any way unless consent has been obtained

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