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Barden is thrilled to be partnering with our client, a leading Biopharmaceutical company, as they expand their Irish and European presence. 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 pivotal 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:
What You will Do:
- 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 organizations (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 to prevent recurrence and strengthen system maturity.
- 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.
