Quality & Compliance Manager

The Quality & Compliance Manager will report directly to the Operations Director and will be responsible for leading and developing the Group Quality Management System (QMS) and broader product compliance framework. Working closely with our external advisors, the role will also cover manufacturing, storage and distribution of Medical Devices (ISO13485, UK & EU MDR) and provision of Pharmaceuticals under the businesses WDA licence. 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.

Key Responsibilities

• Quality Assurance and ISO Certification
  • Own, maintain and continuously improve 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 (CPAP) within agreed timeframes.
  • Drive a culture of continuous improvement across quality and compliance processes.
• Compliance & Regulatory Frameworks
  • 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 (GDP / Responsible Person)
  • Work closely with our 3rd party Pharmaceutical advisors and Responsible Persons (RP) to 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.
  • Participate in MHRA inspections and manage responses to regulatory findings.
  • In time, with training and support, obtain qualification as the company’s Responsible Person (RP) for Wholesale Distribution Authorisation (WDA).
• Medical Device Compliance
  • Work closely with our 3rd party Medical Device advisors to ensure compliance of Medical Device products (including Koolpak, gloves and related ranges) with UK and EU MDR and ISO 13485 standards.
  • Oversee technical documentation, declarations of conformity and product registrations.
  • Ensure post-market surveillance, vigilance and reporting obligations are met.

Person Specification

• Qualifications
  • ISO 9001 Lead Auditor or Internal Auditor qualification. [Essential]
  • Completed GDP training course suitable for RP eligibility. [Desirable]
  • Eligible to act as Responsible Person (RP) under MHRA requirements. [Desirable]
• Skills & Behavioural Competencies
  • Detail-oriented with strong governance mindset. [Essential]
  • Excellent organisational skills, ability to construct and execute structured annual compliance plans [Essential]
  • Ability to construct and implement structured compliance frameworks. [Essential]
  • Excellent analytical and risk assessment capability. [Essential]
  • Confident communicator able to engage with regulators and senior stakeholders. [Desirable]
  • Strong understanding of GDP and Wholesale Pharmaceutical regulations. [Desirable]
  • Proactive and commercially aware approach to compliance. [Desirable]
• Knowledge
  • Understanding of ISO 9001 Quality Management Systems. [Essential]
  • Knowledge of product technical documentation and post-market surveillance requirements. [Desirable]
  • Knowledge of UK Medical Device Regulations (UK MDR). [Desirable]
  • Knowledge of UK GDP and MHRA regulatory requirements. [Desirable]
• Experience
  • Demonstrable track record of implementing and maintaining ISO certifications. [Essential]
  • Proven experience in Wholesale Pharmaceutical distribution environment. [Desirable]
  • Experience in Medical Device compliance environment. [Desirable]

Role Benefits

• Hybrid working (3 days in office minimum)
• Performance based bonus scheme
• 25 days holiday per annum (including Christmas closure) rising to 26 days after 5 years and 27 days after 10 years, plus bank holidays (pro-rated for part-time staff)
• GBP 200 per annum for health and wellbeing activity / gym membership (after 1 year of service)
• Voucher awards for ideas
• Social committee organising departmental events and activities
• Summer BBQ and/or Christmas party for whole company and partners
• Free parking
• Modern offices with kitchen and break facilities
• Community / Charity day with line manager approval
• Opportunity to get involved with events and initiatives to support local charities
• 1 piece of PBH branded merchandise as a welcome / thank you for being part of the PBH team!
• 10% discount at a local independent gym
• Ongoing support, development and training in line with needs of the role and business.
• Financial support to cover cost of specialist eyesight tests for DSE users & glasses for DSE use (including frames that cost up to GBP 50)
• Auto-enrolment for eligible staff - 8% Pension with NowPensions - (3% Employer & 5% Employee on qualifying earnings)