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Quality & Compliance Manager

Job in Milton Keynes, Buckinghamshire, MK10 0BX, England, UK
Listing for: Poole Bay Holdings Management Ltd
Full Time position Listed on 2026-11-08
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
Salary/Wage Range or Industry Benchmark: 50000 - 55000 GBP Yearly GBP 50000.00 55000.00 YEAR

Job Description & How to Apply Below

Quality & Compliance Manager

Final date to receive applications: 31 December 2026

Department: Operations

Employment Type: Full Time

Location: Fleets Corner Business Park

Reporting To: Group Operations Director

Compensation: £50,000 - £55,000 / year

Description

Location:
Poole, Dorset (hybrid working available upon successful completion of training)

Hours:

37.5 per week Working pattern:
Monday - Friday 9:00 until 17:00

The Quality & Compliance Manager will report directly to the Operations Director and will be responsible for leading and developing Group Product Compliance including Wholesale Pharmaceutical Compliance (GDP), Medical Device compliance, Quality Assurance and ISO certification management. The role will ensure the business meets all MHRA, GDP and Medical Device regulatory requirements, acting as the company’s Responsible Person (RP) for Wholesale Distribution Authorisation.

Working closely with our external advisors, the Compliance Manager will establish robust compliance frameworks, proactively identify regulatory requirements across all product categories, and construct structured plans to ensure ongoing compliance across the Group. The role will involve extensive collaboration with other functions such as Warehousing and Distribution, and Supply Chain, to ensure execution against compliance frameworks.

Duties and Responsibilities General Requirements
  • Develop and deliver the PBH Group Product Compliance strategy in alignment with the overall Group Strategy.
  • Identify all applicable regulatory and legal requirements across Pharmaceutical, Medical Devices and other related product categories.
  • Construct and implement structured compliance plans to ensure ongoing regulatory adherence.
  • Establish governance, policies and compliance controls across product life cycles.
  • Provide regular compliance reporting to the Operations Director and Board.
  • Monitor regulatory changes and ensure timely implementation of required updates.
Wholesale Pharmaceutical Compliance (GDP / Responsible Person)
  • Act as the company’s nominated Responsible Person (RP) registered with the MHRA.
  • Ensure full compliance with GDP (Good Distribution Practice) requirements.
  • Maintain and oversee the Wholesale Distribution Authorisation (WDA).
  • Ensure appropriate GDP training, documentation and audit readiness across the business.
  • Lead MHRA inspections and manage responses to regulatory findings.
  • Maintain RP oversight of storage, transportation, supplier qualification and distribution controls.
  • Support, guidance and training will be provided, including from external specialists where necessary.
Medical Device Compliance
  • Ensure compliance of Medical Device products (including Koolpak, gloves and related ranges) with UK and EU MDR and ISO 13485 standards.
  • Collaborate with our external Medical Device consultants to maintain regulatory compliance.
  • Oversee technical documentation, declarations of conformity and product registrations.
  • Ensure post-market surveillance, vigilance and reporting obligations are met.
Quality Assurance and ISO Certification
  • Own and maintain the Group Quality Management System (QMS).
  • Ensure compliance with ISO standards including ISO 9001 and other relevant certifications.
  • Plan and manage internal audits and external certification audits.
  • Implement corrective and preventive actions within agreed time frames.
  • Drive continuous improvement across quality and compliance processes.
Person Specification Qualifications
  • Eligible to act as Responsible Person (RP) under MHRA requirements. [Essential]
  • ISO 9001 Lead Auditor or Internal Auditor qualification. [Essential]
  • Completed GDP training course suitable for RP eligibility. [Desirable]
Skills
  • Ability to construct and implement structured compliance frameworks. [Essential]
  • Excellent analytical and…
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