Quality & Compliance Manager

Poole Bay Holdings Management Ltd; England; Ibrido; GBP 50.000 - 55.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid working after training

25 days holiday per year (plus bankhol

Health and wellbeing allowance

Pension and employee benefits

Parking

Employee recognition programs

Descrizione del lavoro

Poole Bay Holdings Management Ltd seeks a Quality & Compliance Manager to lead and develop Group Product Compliance, including Wholesale Pharmaceutical GDP, Medical Device compliance, and ISO certification management. You will act as the RP for the WDA and ensure MHRA compliance across product categories while collaborating with Warehousing, Distribution, and Supply Chain teams.

The role requires MHRA RP eligibility, ISO 9001 expertise, GDP training, and strong governance capabilities.

Competenze

• Eligible to act as Responsible Person (RP) under MHRA requirements.
• ISO 9001 Lead Auditor or Internal Auditor qualification.
• Completed GDP training course suitable for RP eligibility.

Mansioni

• Develop and deliver the PBH Group Product Compliance strategy.
• Identify regulatory and legal requirements across Pharmaceutical and Medical Devices.
• Construct and implement structured compliance plans.
• Establish governance, policies and controls across product lifecycles.
• Provide regular compliance reporting to the Operations Director and Board.
• Lead MHRA inspections and manage regulatory responses.

Conoscenze

Compliance governance

Analytical risk assessment

Regulator engagement

Independent initiative

Organisational skills

Discretion and confidentiality

GDP knowledge

Commercial awareness

Formazione

ISO 9001 Lead Auditor

RP eligibility with MHRA

GDP training course

Descrizione del lavoro

Quality & Compliance Manager

Application Deadline: 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 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)

• 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.

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 risk assessment capability. [Essential]
• Confident communicator able to engage with regulators and senior stakeholders. [Essential]
• Strategic, pro‑active, and able to work independently on own initiative, making recommendations for change, where appropriate. [Essential]
• Excellent organisational and prioritisation skills. [Essential]
• Discretion and confidentiality when handling sensitive information. [Essential]
• Strong understanding of GDP and Wholesale Pharmaceutical regulations. [Desirable]
• Detail‑oriented with strong governance mindset. [Desirable]
• Proactive and commercially aware approach to compliance. [Desirable]

Knowledge

• Knowledge of product technical documentation and post‑market surveillance requirements. [Essential]
• In‑depth knowledge of UK GDP and MHRA regulatory requirements. [Desirable]
• Knowledge of UK Medical Device Regulations (UK MDR). [Desirable]
• Understanding of ISO 9001 Quality Management Systems. [Desirable]

Experience

• Demonstrable track record of implementing and maintaining ISO certifications. [Essential]
• Proven experience in Wholesale Pharmaceutical distribution environment. [Desirable]
• Experience acting as RP or Deputy RP (or demonstrably eligible to act as RP). [Desirable]
• Experience managing MHRA inspections and regulatory audits. [Desirable]
• Experience in Medical Device compliance environment. [Desirable]

Benefits

• Hybrid working after successful completion of training (3 days in office minimum)
• 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)
• Enhanced Maternity pay
• Enhanced Paternity pay
• Annual Health and wellbeing allowance for activity / gym membership (after 1 year of service)
• Voucher awards for ideas
• Quarterly prize draw (after 1 years service)
• Social committee organising departmental events and activities
• Summer BBQ and/or Christmas party for whole company and partners
• Free parking
• Community / Charity day with line manager approval after successful probation
• 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 £50)
• Auto‑enrolment for eligible staff - 8% Pension with NowPensions – (3% Employer & 5% Employee on qualifying earnings)