Director Site Operations

Director Site Operations

The Director Site Operations will be responsible for site operations including: Manufacturing, Finance, Supply Chain, and Operational Excellence. Must maintain a close partnership with the following organizations; R&D, Quality Assurance, Regulatory Affairs, IT, Finance, Human Resources, Environmental, Health and Safety, Facilities and Program Management. This role operates in a highly regulated environment with complex design and functionality. This position must be able to handle a high number of complex financial, analytical, and strategic considerations in critical decision making. Ensure compliance with all Abbott Corporate quality, financial, regulatory & purchasing.

• Oversee manufacturing activities of multiple product lines operating on multiple shifts. 
• Develop and implements short and long term strategic plans to ensure manufacturing systems are in place to meet business objectives. 
• Work cross-functionally with R&D, Quality, Clinical, Regulatory and other departments as needed to ensure effective new product transitions into production. 
• Work with Supply Chain management to develop effective, production planning and inventory systems; ensure accurate tracking and accounting of materials and WIP. 
• Work with Continuous Improvement and Engineering functions to develop effective manufacturing processes capable of meeting quality, cost and supply chain objectives. 
• Anticipate and resolve highest level issues and conflicts that could impact operations success. 
• Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment. 
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. 
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. 

• Bachelor’s degree in Engineering or similar is required
• Minimum 10 years  progressively responsible leadership experience in a high-volume, multi-product manufacturing environment, preferably in the medical device industry. 
• Significant experience leading and implementing lean manufacturing/Six Sigma initiatives. Solid knowledge of GMP and ISO regulations. Significant experience in identifying and driving operational change and excellence. 
• Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. 
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable. 
• Ability to travel approximately 10%

• Master’s degree in Engineering or similar
• Experience with Class III medical devices

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In specific locations, the pay range may vary from the range posted.