Director of Manufacturing

A Director of Manufacturing is required by CareerWise Recruitment for our Galway based client. Sterile Manufacturing experience is essential!! The Director of Manufacturing will be responsible for all activities relating to the day-to-day manufacturing of pharmaceutical products at the facility. In collaboration with the other members of the site leadership team, the Director of Manufacturing will be part of the senior management team that is responsible for culture, corporate citizenship, strategic planning, and ensuring long term viability of the site. This position has high accountability for decision making and supply chain reliability and will work cross-functionally to ensure the products meet standards for quality, inventory levels are satisfactory, and budget goals are achieved. This position will also be responsible for long term capacity planning.

THE ROLE:

• Responsible for all site manufacturing operations related activities (People, Processes, Financial and other)
• Hiring, building, training and maintaining of resources to build motivated knowledgeable, agile and talent-based manufacturing team
• 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
• Organising inputs across functions to develop defined work plans for process improvements for existing products or to investigate issues related to production deviations
• Recognizing threats to successful manufacturing operations and expediting timely and decisive corrective action
• Justifying capital investment or operational changes that could improve operations at the facility
• Working with Development, Engineering, Quality and other functions to ensure a smooth transfer of technologies and products from Development to commercial manufacturing
• 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 Manufacturing group in consultation with the site General Manager and the 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 manufacturing leadership during internal and regulatory inspections and to participate in the Internal and External Auditing Program.
• In close collaboration with the broader team 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.
• Providing input, and review to the design, construction, qualification and start-up of an expanded Manufacturing facility.
• 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 Manufacturing groups.
• 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 of the manufacturing department.

REQUIREMENTS:

• Bachelor’s Degree in Engineering, Manufacturing, or a related discipline
• 7 - 10 years in Sterile Manufacturing
• Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
• Aseptic Process Expertise, proven experience in contamination control strategies, including cleaning and disinfection validation.
• Leadership Skills: Strong ability to mentor and develop teams
• Risk assessment & problem solving capabilities
• Communication & Collaboration: Excellent ability to articulate requirements and collaborate cross-functionally to drive compliance and process improvements

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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