A leading global Pharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Selling into over 100+ countries with with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. Expanding heavily here in Ireland with the acquisition of a number of maufacturing sites, this business has invested heavily in its Biologics flagship manufacturing operation here in particualr and currently require a Quality Director to head up all Quality activities at the site.
- The Site Quality Leader (SQL) role is accountable for product quality and the site's regulatory compliance standing- maintaining a state of inspection readiness.
- The SQL ensures that the Quality systems and processes implemented at the site meet all international quality, regulatory and compliance standards.
- Responsible for the development and growth of the Quality Organisation, offering a proactive service across Quality Control, Quality Operations, Quality regulatory compliance and Quality Assurance.
- Accountable for product quality and the site's regulatory compliance standing - maintaining a state of Inspection Readiness. The Role ensures the Quality functions meets all regulatory compliance requirements and GMPs.
- Support site manufacturing activities and ensure compliance to standards and regulations throughout the product lifecycle.
- Champion the Quality Culture and takes proactive steps to prevent any decay in the state of quality and compliance at the site.
- The position reports to the Platform Quality Leader, participates as a contributing member of the Site Leadership Team, and participates in setting the strategic direction of the quality unit and the site as well as managing day-to-day quality operations. The position also co-chairs the site Quality Council (with the Site Lead) to drive continuous improvement and compliance objectives as well as prioritizing quality improvement initiatives.
- The role has ownership of the Site Risk Assessment Process - leading the Site Leadership through the process on a predetermined cadence.
- The Quality Lead uses data and metrics to drive continuous improvement in site quality systems as well as Product Quality. Additonally - the role is responsible for creating and executing the Site Quality Roadmap
- Educated to Degree/MSc level with 10 years' plus experience in Bio/Pharma QA/QC/Compliance roles. Demonstrated proficiency in application of QA principles, concepts, industry practices and standards gained from previous QA/QP positions.
- Registered Qualified Person is preferential
- Previous experience leading and engaging a successful team a must.
- Proven product launch experience and biologics knowledge advantageous.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.