GMDP Quality Assurance Manager

Wepclinical; Dublin; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Group Private Medical Insurance

Group General Life Assurance

Educational Assistance allowance

Paid volunteering day

Job summary

WEP Clinical is seeking a GMDP Quality Assurance Manager to lead quality assurance operations. The role involves ensuring compliance with GMP/GDP regulations and overseeing the Quality Management System (QMS).

The ideal candidate will have over 5 years of experience and a degree in a relevant field, with strong leadership and communication skills. Benefits include private medical insurance and educational assistance.

Qualifications

• 5+ years of related industry experience.
• Experience with UK, FDA, and EU regulations is required.
• Ability to balance business need and Quality requirements.

Responsibilities

• Lead and manage day‑to‑day site quality assurance operations.
• Ensure compliance with GMP/GDP regulations.
• Conduct risk assessments to support quality decisions.

Skills

Attention to detail

Strong leadership mindset

Excellent communication skills

IT literate: Microsoft Outlook, Word, Excel

Proactive and self-motivated

Education

Bachelor's Degree in pharmaceutical, life sciences, or engineering

Job description

Overview

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission‑driven organisation dedicated to advancing clinical research and transforming lives.

Role Objectives

The WEP Clinical GMDP Quality Assurance Manager will be responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities. They will oversee and drive day‑to‑day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements. The GMDP Quality Manager will also act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

Key Responsibilities

• Lead and manage day‑to‑day site quality assurance operations.
• Maintain and ensure compliance with the site Quality Management System (QMS).
• Ensure compliance with GMP/GDP regulations and relevant regulatory requirements.
• Oversee and ensure timely completion of quality records (e.g., deviations, complaints, CAPAs and Change Controls, Customer Verification), ensuring effective investigation and root cause analysis.
• Complete critical warehouse reviews as the Responsible Person, Deputy Responsible Person, or Equivalent Delegate, verifying warehouse maintenance programs have been completed (e.g., pest control, cleaning reports, calibration reviews).
• Conduct and oversee risk assessments to support quality and business decisions.
• Review and approve executed batch records, ensuring product packaging activities have been performed in accordance with packaging specifications and internal SOPs.
• Effectively host or delegate self‑inspections, client audits and/or regulatory inspections, ensuring timely follow‑up to reports and robust CAPAs.
• Lead, coach, and develop the QA site operations team to drive a cohesive and highly effective team.
• Work closely with cross‑functional teams (e.g., supply chain, logistics, and project teams) to ensure compliant delivery of services.

Qualifications

• Attention to detail
• Proactive and self‑motivated
• Calm and logical under pressure
• Confident communicator
• Strong leadership mindset
• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 5+ years of related industry experience
• Proven leadership and management capabilities
• Ability to plan and organise effectively, working on multiple priorities to strict deadlines with a high level of accuracy
• Experience with UK, FDA, and EU regulations, pertinent to manufacturing and distribution operations is required
• Strong understanding of fundamental principles for core Quality Management System processes (e.g., risk assessments, deviations, change control, supplier/customer management)
• Extensive knowledge of Good Manufacturing and Distribution Practice including data integrity principles and label control
• Ability to balance business need and Quality requirements, identifying ways to meet both aspects
• Excellent communication skills: verbal and written
• Ability to effectively communicate and navigate various stakeholders in management and non‑management positions to drive action and project completion including explaining complex quality issues to non‑quality personnel
• IT literate: Microsoft Outlook, Word, Excel is essential
• Ability to remain in a statutory position for extended periods as part of normal day‑to‑day activities, with reasonable adjustments considered where appropriate

Benefits

• Group Private Medical Insurance
• Group General Life Assurance
• Group Critical Illness and Group Income Protection
• Salary sacrifice pension scheme
• Enhanced maternity & paternity pay
• Educational Assistance allowance
• Paid volunteering day

Equal‑Opportunity Employer

WEP Clinical is an equal‑opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.