Quality & Compliance Manager

Poole Bay Holdings; Poole; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Poole Bay Holdings in Poole, Dorset, is seeking a Quality & Compliance Manager to lead Group Product Compliance across GDP, Medical Device compliance, and ISO certification management. This role reports to the Operations Director and acts as RP for WDA with MHRA.

The position supports hybrid working after training and requires coordinating with Warehousing, Distribution and Supply Chain to ensure regulatory adherence and continuous improvement across product lifecycles.

Responsibilities

• Develop and deliver the PBH Group Product Compliance strategy in alignment with the overall Group Strategy.
• Identify regulatory and legal requirements across Pharmaceutical, Medical Devices and related product categories.
• Construct and implement structured compliance plans to ensure ongoing regulatory adherence.
• Establish governance, policies and compliance controls across product lifecycles.
• Lead MHRA inspections and manage responses to regulatory findings.
• Collaborate with Warehousing, Distribution and Supply Chain to ensure execution against compliance frameworks.

Job description

We are a leading UK B2B eCommerce and catalogue marketer with product marketing expertise across a wide range of health, safety, and facilities products.

Quality & Compliance Manager

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

Working pattern: Monday – Friday 9:00 until 17:00

Duties and Responsibilities

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.

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 lifecycles.
• Provide regular compliance reporting to the Operations Director and Board.
• Monitor regulatory changes and ensure timely implementation of required updates.

Wholesale Pharmaceutical Compliance (GFP / 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 timeframes.
• Drive continuous improvement across quality and compliance processes.