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GMDP Quality Assurance Manager

WEP Clinical -
Dublin, County Dublin

Apply Now

Job details

Full-time

Benefits

Private medical insurance

Qualifications

Microsoft Word
Microsoft Excel
Microsoft Outlook
Supply chain
Logistics
English
Quality management
Bachelor's degree
Manufacturing
Leadership
Communication skills

Full job description

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.

The Ideal Candidate:

Attention to detail
Proactive and self-motivated
Calm and logical under pressure
Confident communicator
Strong leadership mindset

What You'll Do:

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 where applicable, 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.

What You'll Need:

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

What We Offer:

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

What Sets Us Apart:

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalised service of a specialised provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn life page to learn more about our team events and all that we do to support our employees.

How We Work at WEP Clinical:

At WEP Clinical, we look for individuals who are conscientious, exercise sound judgement, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives – and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services Include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialisation

Data Privacy Notice:

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.

Job Applicant Privacy Notice: https://www.wepclinical.com/privacy-policy/

How to Apply:

To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.

Important Note:

To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.

For Your Safety, Please Note:

We will never communicate with you via Microsoft Teams or text message

We will never ask for your bank account information at any stage of recruitment.

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

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.

#LI-fulltime #LI-hybrid

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Apply Now

Refine Your Search

clinical trials jobs in dublin, d

GMDP Quality Assurance Manager

Programme Lead

Principal Biostatistician (R/Rshiny - EMEA BASED)

Associate Director, Statistical Programming

Business Support Specialist 12 month Fixed Term Contract

FICO Business Analyst

Associate Biostatistics Director - FSP (Permanent Home-based)

Revenue Accountant

Associate Director, Biostatistics

Service Delivery Director

DevOps Engineer

Mid-Level Backend Software Engineer

Senior Enterprise Account Manager, AGS Ireland/NI (Cross Industries)

ServiceNow Architect

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