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 additionally recently acquired office space in South Dublin and is now recruiting heavily into this operation.
As EMEA Quality Director, you will ensure ESQA (External Supply Quality Assurance) develops links, collaborates and partners with other business functions (e.g. External supply, Procurement, Regulatory, R&D, Sites, Global Technology Services, Business Development, Supply & Logistics, GQCA) to effectively manage Quality and regulatory compliance in third party manufacturing and tolled material to third parties. In addition, you will:
- Establish and align within ESQA with other teams/platforms/regions on policies, common systems, procedures and processes and their application within the team responsible for European, African and Middle East manufacturing 3rd parties.
- Manage teams located in Europe and other remote locations within the region of Africa and Middle East.
- Guide and mentor colleagues in quality management and oversight of 3rd party manufacturers to FDA/USDA/EU GMP and other regulatory requirements within a multicultural contractor base, wide product portfolio and colleague base.
- Ensure the team works to implement business expectations and requirements at 3rd party manufacturers and resolve differences to policies.
- Manage resources within the group to balance workload, experience and development/training needs across the team.
- Manage Quality and Compliance issues at 3rd parties within the Notification to Management system and implementation of notification to management process.
- Work with country leaders in aspects of Quality management of Manufacturers serving only one market and not managed by External Supply to ensure consistent policies and systems are applied.
- Take on responsibilities in assignments/projects from leadership and allocate team resources to support projects, initiatives, new business opportunities or other product related projects at third parties or within the organisation.
- BSc, BM, MS or PhD in pharmaceutical sciences, engineering, chemistry, biology or equivalent degree.
- Minimum 15 years of relevant pharmaceutical industry experience in Quality Assurance and/or Manufacturing.
- Demonstrated leadership skills in direct supervision of a team or organisation.
- Broad experience that may include multifunctional, multisite or other functional experience.
- Leadership and partnering experience on multidisciplinary teams or projects.
- Working with multicultural, cross-functional work teams.
- Experience in Quality Compliance functions.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.