Practice Lead | Talent Advisory & Recruitment |
Barden is thrilled to be partnering with our client, a leading Biopharmaceutical company, as they expand their Irish and European operations.
They are now seeking a Quality Assurance Lead, to play a key role in this pivotal phase of growth.
As Quality Assurance Lead for Europe, you will play a key role in shaping the future of their Irish and European operations.
This is a unique opportunity to combine strategic oversight with hands-on execution.
If you are looking for a chance to make real, lasting impact and help shape a company's growth story, this role offers exactly that.
ABOUT THE ROLE
Lead the deployment and validation of Veeva eQMS for document control, deviation, CAPA, and change control management.
Author and manage Quality Manuals, SOPs, and governance policies to ensure traceability, scalability, and operational efficiency.
Administer the QMS post-implementation, driving continuous improvement and process harmonization across product categories and global interfaces.
Design, implement, and maintain a fit-for-purpose PQS that supports MAH and WDA obligations, aligned with EU GMP, GDP, and ICH Q10 principles.
Act as a primary QA contact with HPRA, MHRA, and other competent authorities during inspections, audits, and regulatory interactions.
Ensure all aspects of product release, distribution, and market quality align with regulatory commitments and approved dossiers.
Establish and maintain the supplier quality management system, including qualification, audits, ongoing monitoring, and periodic performance reviews.
Oversee contract manufacturing organisations (CMOs), contract testing laboratories, and quality-relevant service providers to ensure adherence to technical agreements.
Oversee product lifecycle quality, including batch documentation review, complaint management, Product Quality Reviews (PQRs), and trending.
Lead or support root cause investigations, risk assessments, and CAPA implementation.
Collaborate with Regulatory Affairs and Pharmacovigilance to ensure post-market quality alignment across labelling, variations, and product changes.
ABOUT THE PERSON
10+ years of experience in Quality Assurance or compliance, ideally within a MAH, CMO oversight, or pharmaceutical distribution setting.
Bachelor's degree: Ideally in Chemistry, Microbiology, Pharmaceutical Sciences, or a related life science; advanced degrees are a plus.
Experience with Veeva, Trackwise, MasterControl, or similar systems.
Proven track record in designing, implementing, or modernizing Quality Management Systems (QMS/PQS) fully compliant with GMP and GDP standards.
Hands-on experience managing regulatory inspections and audits (HPRA, MHRA, EMA, FDA).
Supplier qualification, vendor management, and oversight of external manufacturing partners.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Cork, County Cork, Ireland €65,******-€75,******** weeks ago
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