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Senior Manager Product QA

Reference:ANPV-376035 Location: Sligo
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person, Quality Manager

Senior Manager, Product QA
Our client, a global biopharmaceutical organisation based in Sligo, are currently recruiting for a Senior Manager, Product QA to join their team on a permanent basis. As Senior Manager you will to lead a technical team of 6 experienced Quality and Regulatory professionals, including 3 QPs. The successful candidate will be responsible for the release of all finished products from the site across API and Drug Product.

• Managing the QP and Regulatory group, including batch release, product performance, new products introduction (NPI) and regulatory support
• Ensuring that products manufactured on site meet requirements of end users, Regulatory Authorities and of the company
• Ensure the batch and its manufacture complies with the provisions of the marketing authorisation
• Ensure manufacture has been carried out in accordance with Good Manufacturing Practice
• Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records
• Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority
• Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
• Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so
• Responsible for oversight of product performance process
• Ensure compliance with Quality Risk Management processes and procedures
• Liaising with Global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies
• Ensure effective transfer of NPIs to site and its progress into commercial manufacturing.

• Third level qualification in a science discipline with minimum 5 years’ experience in the healthcare/pharmaceutical industry
• MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• Minimum 5 years industrial experience gained in a FDA and EMA approved pharmaceutical environment.

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252

Limerick Medical Affairs Pharmaceutical Dublin West Life Science Project Lead Quality Control Manager Kildare Senior Research and Development Engineer Biopharmaceutical Pharmacist Food Scientist Biotechnologist Engineering QA Specialist Galway Quality Systems Lead Scientific Sales Equipment Engineer Senior Scientist Quality Systems Specialist Project Engineer Process Engineer Nurse Associate Academic Contract Regulatory Affairs Specialist Research Scientist Validation Manager Cork Qualified Person Validation Engineer Biochemist Quality Manager EHS Specialist Automation Software Controls Manager QA Executive Validation Specialist Validation Scientist R and D Manager Account Manager Scientist Scientific Planner Sales Executive Dublin BD Manager Medical Device Chemistry Republic of Ireland Biomedical Engineer Project Manager Manufacturing Engineer Research and Development Scientist Supply Chain Coordinator Clinical Research Supply Chain Formulation Chemist QA Supervisor Medical Advisor QC Analyst Manufacturing Coordinator Chemist Biotechnician Supply Chain Administrator Sales Consultant Westmeath Biostatistician Formulation Scientist Engineering Academic Manufacturing and Technology Manager Contract Principal Scientist QA Analyst Sales Specialist Quality Assurance Regulatory Affairs Manager Quality Control Supervisor Medical Director Dublin North Regulatory Affairs Sligo Quality Auditor Automation Engineer QA RA Engineer MES Consultant Quality Specialist Dublin South Microbiology Healthcare Sales Development Executive Regulatory Affairs Supply Chain Specialist Biotechnology Process Development Engineer Engineering Manager Life Science EHS Engineer QA Manager PhD Connected Health Quality Assurance Officer Supply Chain Validation Coordinator Bioprocess Engineer