Our client, a leading pharmaceutical company are seeking a Director of Quality who will be based in West Dublin, that will lead and build a dynamic Medical Device QA team focused on standardizing and deploying best in class quality processes and communications across the Dublin campus.
The role will lead the engagement and interaction with key internal customers specifically Design, Operations, Engineering and Continuous Improvement teams and will be first point of contact for key strategic external customers.
The role provides exemplary leadership, management, and direction to deliver on quality strategies, key performance indicators including, safety, quality, on-time delivery, and efficiency targets. Leadership capacity to effectively engage with local and global leaders to deliver on global solutions and innovation is a key component of this role. The role will drive engagement across multiple sites in West to support common customer programs and medical device platform alignment.
Essential Duties and Responsibilities:
- As a member of the Site Leadership Team, deeply engages and effectively contribute to the achievement of site objectives by playing an active role in the strategic planning processes.
- Directs and leads the Quality function for combination medicinal products, investigational medicinal products (IMP) and medical device products molded, assembled, and packed by Tech Group Europe (t/a WEST) to meet and exceed all regulatory requirements, customer requirements and key performance indicators.
- Develop the organizational structure and talent to execute the West Dublin Quality imperatives and site strategy.
- In accordance with EU, US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations and registrations.
- This role will have responsibility as the Global Lead for Data Integrity across all Contract Manufacturing/ Medical Device.
- Ensure all products are developed, manufactured, tested, stored, and distributed in accordance with regulatory (e.g. US FDA, cGMP, ISO requirements), customer and West standards, guidelines and procedures. Directs Quality team to meet and exceed all key performance indicators.
- Leads, develops, and executes on the quality strategy for the West Dublin campus, ensuring alignment to the global vision and strategy and defining quality objectives in line with overall Contract Manufacturing/ Medical Device quality objectives.
- Ensures the promotion of awareness of applicable regulatory and Quality System requirements throughout the organization and champion the highest levels of patient first/ quality culture, customer service and engagement.
- Bachelor’s Degree in a technical discipline to include; Science, Quality or Engineering. Master’s degree a plus.
- Minimum of 10 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry.
- Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven
- Ideally be minimum ‘Greenbelt’ Lean Sigma trained with a proven track record of leading multiple value-add programs.
- Excellent computer skills, experience with MS Office, ERP systems, Statistical software etc.
Great remuneration package and benefits come with this role.
For further information please contact and send your updated CV to Stefan Ion in confidence at [email protected] if you are interested in finding out more about the role and would like to be considered.
If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.
Osborne are proud to be an Equal Opportunity Employer