GMDP Quality Assurance Manager

About the Role

Join WEP Clinical as a GMDP Quality Assurance Manager in Dublin, Ireland, where your leadership will be vital in managing site quality assurance focused on manufacturing and distribution, particularly in secondary packaging and labelling. This position ensures adherence to Good Manufacturing and Distribution Practice (GMP/GDP) regulations and fosters operational excellence across clinical trial supply activities.

Key Responsibilities

• Oversee daily quality assurance operations at the site, ensuring all practices comply with relevant regulatory standards and quality management systems.
• Maintain the Quality Management System (QMS) compliance, managing deviations, complaints, CAPAs, change controls, and customer verifications with thorough investigations and root cause analysis.
• Serve as Responsible Person or Deputy in conducting critical warehouse assessments, including pest control, cleaning procedures, and calibration verification.
• Lead risk assessments to inform quality and business decisions effectively.
• Review and authorize batch records confirming packaging compliance with specifications and SOPs.
• Lead or delegate internal audits, client inspections, and regulatory evaluations, ensuring prompt corrective actions and comprehensive follow-up.
• Manage, mentor, and develop the QA operations team to create a cohesive and high-performing department.
• Collaborate closely with supply chain, logistics, and project management teams to deliver compliant and timely service solutions, especially within Post Approval Named Patient, Expanded Access Programs, and Clinical Trial supply lines.

Candidate Profile

• Bachelor’s degree or higher, preferably in pharmaceutical, life sciences, or engineering fields.
• At least 5 years of industry experience with proven leadership and managerial skills.
• Strong organizational skills with the ability to multitask and prioritize deadlines accurately.
• In-depth knowledge of UK, FDA, and EU regulations relevant to manufacturing and distribution.
• Firm understanding of core Quality Management processes such as risk assessments, deviations, change controls, and supplier/customer management.
• Comprehensive expertise in GMP/GDP, data integrity, and label control policies.
• Capability to balance business objectives with strict quality requirements.
• Excellent verbal and written communication skills, able to articulate complex quality issues to diverse stakeholders.
• Proficiency with Microsoft Outlook, Word, Excel.
• Willingness and ability to maintain statutory roles consistently, with reasonable accommodations as needed.

Benefits and Culture

• Group private medical insurance and life assurance coverage.
• Group critical illness insurance and income protection policies.
• Salary sacrifice pension plan.
• Enhanced maternity and paternity leave benefits.
• Educational assistance allowances and paid volunteer days.

About WEP Clinical

WEP Clinical partners with biopharmaceutical sponsors worldwide to facilitate clinical trial delivery, expanded access, and market access consultancy, impacting patient care globally across 150+ countries. The organization emphasizes integrity, accountability, respect, and inclusivity to foster a supportive workplace that encourages growth and excellence.

Additional Information

WEP Clinical maintains a smoke-free, drug-free, and alcohol-free workplace and is an equal opportunity employer committed to reasonable accommodations for qualified individuals with disabilities. They use AI tools to assist in recruitment decisions, though final hiring decisions are human made. Applicants are advised to apply through official channels only and remain cautious of fraudulent communications throughout the hiring process.

Data Privacy

The company follows strict privacy policies for handling applicant information as detailed on their privacy and job applicant notices.