Quality Operations Lead, Biotech GMP & Compliance

Life Science Recruitment; Leinster; On-site; EUR 70,000 - 90,000; Full time

Job summary

Life Science Recruitment is recruiting for an award-winning pharmaceutical organisation based in Louth. The role will oversee QA for clinical and commercial operations across the biotech facility, driving quality, EHS, learning, and continuous improvement in line with cGMP regulations.

You will collaborate with Manufacturing Operations, MS&T, and Engineering to resolve issues, execute quality systems, manage CAPAs, change controls, deviations, and batch documentation review, ensuring regulatory

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in biotechnology/pharmaceutical industry.
• Previous experience with deviation management/Change controls.
• Previous experience in Batch Record Review is preferable.
• Knowledge of cGMP regulations both domestic and international.

Responsibilities

• Provide QA oversight to clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing and support process technical transfers, analytical technical transfers, drug substance disposition and regulatory approvals.
• Support the execution of an effective Quality system and accountability for quality management systems (CAPAs, Change Controls, Deviations, Batch Documentation Review).
• Liaises with internal partners to support daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensure clear communication on issues and timely escalation as applicable.
• Maintain site practices and procedures related to clinical and commercial operations.
• Adhere to domestic and international GMP regulations, cGMPs, company policies, leadership behaviours, and performance and budget management.
• Champion site metrics to ensure targets are achieved with counter measures.
• Represent Quality on multidisciplinary teams and execute company policies.
• Ensure new/revised quality system requirements are deployed to the Site.

Skills

QA oversight

cGMP compliance

Change controls

Deviation management

Batch documentation review

Regulatory approvals

Quality systems

Problem solving

Education

Science/Pharmacy degree

Job description

Life Science Recruitment is recruiting for an award-winning pharmaceutical organisation based in Louth. The role will oversee QA for clinical and commercial operations across the biotech facility, driving quality, EHS, learning, and continuous improvement in line with cGMP regulations.

You will collaborate with Manufacturing Operations, MS&T, and Engineering to resolve issues, execute quality systems, manage CAPAs, change controls, deviations, and batch documentation review, ensuring regulatory