Interim Head of Quality and RP/RPi

Walker Cole International is supporting a Dublin-based life sciences organisation in the appointment of an Interim Head of Quality / Responsible Person (RP) / Responsible Person for Import (RPi). This role will provide leadership and oversight of the Quality function, ensuring compliance with GDP and relevant regulatory requirements while supporting ongoing operational activities within a regulated environment.

This position will play a critical role in maintaining and enhancing the organisation’s Quality Management System, ensuring compliance with global regulatory standards, and acting as a key point of contact with regulatory authorities. The successful candidate will provide strategic and operational leadership across quality systems, distribution activities, and cross-functional teams.

Key Responsibilities

• Act as Responsible Person (RP) and RPi, ensuring compliance with GDP and applicable EU regulations

• Provide leadership and oversight of the Quality Management System (QMS)

• Ensure all QMS processes remain compliant with regulatory requirements and industry standards (e.g. GDP, GxP)

• Oversee and approve quality processes including deviations, CAPA, change control, complaints, and document control

• Maintain oversight of product release, importation, storage and distribution activities

• Act as the primary quality representative during regulatory inspections (e.g. HPRA/MHRA)

• Ensure the organisation maintains a state of inspection readiness at all times

• Provide guidance on best practices for QMS structure, governance, and continuous improvement

• Collaborate with quality, regulatory, supply chain, and operational teams to ensure compliant processes

• Oversee supplier qualification, third-party management, and quality technical agreements (QTAs)

• Support and mentor QA teams, fostering a strong quality culture across the organisation

• Review and approve key quality documentation including SOPs, policies, and records

Required Experience and Skills

• Proven experience as a Head of Quality, RP and/or RPi within the pharmaceutical, biotech, or life sciences sector

• Strong working knowledge of GDP regulations and EU regulatory requirements

• Extensive experience managing and maintaining Quality Management Systems (QMS)

• Demonstrable experience in regulatory inspections and audit readiness

• Strong expertise in quality processes including CAPA, deviations, change control, and supplier management

• Experience overseeing importation, distribution, and release of medicinal products

• Ability to work collaboratively with cross-functional stakeholders across quality, regulatory, and operations teams

• Strong leadership, organisational skills, and attention to detail

• Excellent communication skills with the ability to engage with regulators and senior stakeholders

Working Pattern

Hybrid (Dublin, Ireland)

Contract Length

6 months

Rate

Day rate negotiable depending on experience

Location

Dublin, Ireland

Keywords

Head of Quality | Responsible Person | RPi | GDP | QMS | GxP | CAPA | Distribution | Pharma | Biotech | Contract | Regulatory Compliance

Job ID

100630

Contract Information

Email: fk@walkercole.com
Telephone: 0208 103 5472