This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the Biopharmaceutical and related industry sectors from contract development services right through to contract manufacturing services to some of the largest biopharma and pharma organisations globally. Recently, this business has announced expansions into geographies such as the U.S and most recently Ireland, where significant investment has been undertaken to build a new cell culture green-field manufacturing site which once built, will be the largest single use biologics manufacturing plant globally. This site has been designed to run continuous bioprocessing, a next-generation manufacturing technology which will be implemented for the first time at this site and once complete will employ in the region of 400 staff. With this expansion, an exciting opportunity has arisen for a QA Supplier Auditor Associate Director to join the organisation at the start-up phase in leading this business through construction and into manufacturing.
- The QA Supplier Auditor will determine the yearly supplier auditing programme after discussions and aligned with global supplier audit team, to assure compliance with all regulatory, market, EU, FDA and company standards.
- The QA supplier auditor will ensure a programme of supplier audits are in place and will audit suppliers as per the audit schedule.
- S/he will ensure accurate reporting of all audits in a timely manner and ensure relevant and appropriate documentation is in place demonstrating outcome of each Audit/assessment.
- S/he is responsible for the review of audit responses from the supplier and follow up with the corrective/preventative actions.
- S/he will work closely with associated suppliers and conduct annual supplier performance review.
- S/he will report associated trends of suppliers/vendors to site management team and liaise accordingly with vendors on material quality complaint and Corrective/Preventative action programmes.
- The lead in this role will be responsible for managing a team of employees across Auditing programmes & Risk assessment. S/he will be responsible for ensuring all associated performance management requirements are in place for each employee and relevant reviews are carried out regularly.
- In addition, s/he is responsible for relevant training is provided to employees who carry out inspection duties on supplier commodities/ingredients etc to ensure accurate identification of deviations or out of spec issues.
- S/he will liaise actively with cross functional teams when approving suppliers and in addition where changes to suppliers may take place.
- Strong QA supplier audit experience.
- It is desirable s/he has a knowledge of legislative, regulatory, market and biologics requirements.
- Preferable that the individual has qualification Degree in Biopharmaceutical Science or other related science discipline.
- It is advantegous if the individual has over 10 years working experience in bio/pharma or similar experience in a pharma/science background, at least 5 years supplier audit experience.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321865 for a confidential discussion.