This global Pharmaceutical leader focuses on improving patient's 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 of drug products and finished product are performed in a safe, compliant manner, meeting the regulatory requirements defined in the Global Procedures and Directives; relevant health authority submissions; cGMP and local Health & Safety requirements.
- Provide strategic and tactical leadership input to the internal operations organization for the manufacture of commercial and development products.
- Direct strategic planning and the development of goals, objectives, and policies for the Quality group in consultation with the Head of Global Quality Operations, Head of Site Operations and the site leadership team.
- Determine group structure; ensure the development of talent for leadership roles; plan talent succession and carry out performance assessments of department sub-ordinates.
- Provide effective Quality leadership during internal and regulatory inspections and to participate in the Internal and External Auditing Program.
- Assure the cross regional systems implementations are integrated and provide the highest level of efficiency. This includes, but is not limited to: Laboratory Process optimization, Operational Excellence compliance level setting and Global Strategic IT implementations (LIMS, TrackWise, Documentum etc.).
- Recommend actions or policies that result in quality operational sites enhancements for compliance 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 that CAPA commitments are implemented in a timely manner and its effectiveness in monitored periodically.
- Ensure sound release decisions are made that adhere to multiple worldwide jurisdictional requirements including cGMP, GCP, GLP, ISO13485 /CMDCAS requirements.
- 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.
- Maintenance of the Manufacturing Licenses, Site Master File and act as a liaison with Regulatory Authorities (IMB/FDA etc.).
- Review departmental business operations/strategies and evaluate possible integration of new tools and technology to increase departmental efficiencies and effectiveness.
- Manage the resources in a planned way to ensure the performance and utilization of resources to provide maximum efficiency to the Product Development and Supply Chain departments.
- Utilize the quality team management resources to reduce cost and deliver more efficient processes.
- Manage and maintain robust relationships with the internal leadership team, industry colleagues and with the HPRA & FDA organizations.
- Minimum of a Bachelor's degree (or equivalent) and a minimum of 10 years of Quality Management experience in a leadership role managing quality operations within the pharmaceutical or related industry.
- Must possess knowledge and understanding of worldwide requirements of cGMP and Quality Systems for Commercial and Clinical products.
- 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 organized 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 Shane Browne on + 353 1 6321865 for a confidential discussion.