POSITION SUMMARY

The Director Operations is responsible for providing key leadership, direction, organization, management, monitoring, cGMP and EHS compliance of the roles, activities and proceedings of all assigned production personnel to ensure the successful, cost effective, timely and sage production and packaging of pharmaceutical solid dosage forms. In addition, she/he is responsible for all new product introductions (NPI) and for the operational part of asset maintenance in the production and packaging area. The position holder will serve as a member of the site leadership team.

• Lead and control of safe, GMP compliant, cost-efficient and stable manufacturing and packaging processes of solid dosage forms (among other tablets, capsules) as well as vials, syringes, bottles for clinical trials.
• With the Heads of Production (HoP) for Packaging and Manufacturing, continually establish the appropriate organizational structure and staffing levels for the manufacturing and packaging areas. Supervise, direct and develop the HoP for Manufacturing and Packaging.
• Accountable for driving change initiatives, innovations and fostering associate involvement, to enhance accountability and sense of urgency throughout entire area of responsibility.
• Develop, implement, review suitable KPIs and ensure appropriate actions are taken to continuously improve cost efficiency, safety, quality and compliance for all processes in manufacturing and packaging.
• Builds and develops a committed team to manage all aspects of area of responsibility as it applies to order fulfillment, including such business processes as order and personnel planning and scheduling, continuous improvement in productivity, implementation and sharing of best practice, quality and business and processes and cost control.
• Develop continual process improvement and capital improvement plans to keep the Manufacturing and Packaging capabilities state of Collaborate with the Black Belts/ Lean Six Sigma associates to drive implementation maintenance of “Best Practice” processes, such as Lean Manufacturing, Standard Work, Six Sigma, TQM and similar tools.
• Develop capital expenditure proposals, justifications and recommendations
• Ensures compliance with all applicable corporate and regulatory SOP and cGMP guidelines in Manufacturing and Packaging, working with site Quality Director.