This global pharmaceutical leader focuses on improving patients' lives by identifying, developing, and commercialising meaningful products that address unmet medical needs. Since their founding, they have focused on putting the patient first and this remains their priority as they continue to develop, acquire, and commercialise new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 40,000 staff globally with offices in the U.S. and Europe, they are a continually growing company with a broad portfolio and a very healthy pipeline. This organisation has an incredible manufacturing footprint here in Ireland and one of their plants is currently in need of a Senior Director of Quality to lead all Quality operations at this expanding site.
- Ensure the manufacture, releases of site products, and Quality Systems are in alignment with QPEU directives, relevant health authority submissions, cGMP's and company policies and procedures.
- Provide strategic and tactical input to the site initiatives inclusive of products transferences, enterprise systems implementation, key systems, and processes changes.
- Direct strategic development, planning and execution of goals in alignment with global objectives.
- Assure an efficient performance of the Quality Unit groups and GMP required systems through continuous review of resources and systems throughput, implementation of new tools, technology and business processes, and adequate coaching for situations that may arise.
- Provide effective Quality leadership during internal and regulatory inspections.
- Recommend actions or policies that result in compliance enhancements and inspection readiness. Maintain a leadership role in establishing and promoting quality improvement activities as a foundation for productivity improvement and business success for the site including commitment to Operational Excellence.
- Ensure site and company metrics are managed per expected timelines and that changes and corrective/preventive actions are monitored for their effectiveness.
- Participate in the approval of key Quality Systems records.
- Maintain the site required licenses, site master file, etc.
- Manage and maintain robust relationships with the Viatris internal leadership team, industry colleagues and with the HPRA & other Health Authorities, as applicable to the site.
- Determine group structure, ensure the development of talent for effective succession and carry out performance assessments of department sub-ordinates.
- Coordinate the forecasting process for required business statistics/information and reporting, and the operational/expense budget and capital budget. Review monthly budget performance and control staffing/headcount across the Quality groups.
- Minimum of a Bachelor's degree (or equivalent) with concentration in any science branch and a minimum of 10 years of Quality Management experience in a leadership role, managing quality operations within the pharmaceutical industry. Experience understanding chemistry laboratory and drug product manufacturing operations is highly preferrable. However, a combination of experience and/or education will be taken into consideration.
- Must possess knowledge and understanding of worldwide requirements of cGMP and Quality Systems and general key initiatives from the Health Authorities.
- Must comprehensively understand chemistry laboratory operations and pharmaceutical stages related to drug products and packaging operations and investigational situations associated to this type of manufacturing.
- Substantial prior experience of forming effective relationships at all levels, must be able to work closely with both Global Quality Leaders and Site Leadership team to ensure alignment with corporate objectives and compliance decision making processes.
- Must be an organised individual who can handle multiple programs and priorities simultaneously.
- Proven track record of successfully creating and managing a highly talented, engaged and performing team with a demonstrated ability to develop and build team culture and spirit.
To learn more about this role apply online or contact Ciaran McCaughey on + 353 1 6321830 for a confidential discussion.