The Site Head of Operation develops and implements a variety of strategies to maximize revenue while maintaining the highest level of quality, as well as working on improving the manufacturing operation to positively impact cost, quality and delivery time. The site Head of Operations provides oversight and guidance to subordinates as well as timely feedback to department leaders on operations-related issues, demonstrating a thorough knowledge of the company's services, client's projects in addition to regulations and industry best practices.. Essential Functions and Responsibilities. Directly accountable for the Manufacturing, Engineering and Facilities Operations, Environmental Health and Safety, Supply Chain, Validation, Manufacturing Science and Technology, Project Management and Human Resources for the site operations.. Indirectly accountable for the Quality Assurance and Quality Control, from a business direction, informational respect and regulatory guidance.. Develops and implements operational strategy for the site including (but not limited to) appropriate budget, investment, staffing and accurate reporting of billable and non-billable hours for all client projects.. Assists the Technical Operation head and the Leadership team in the implementation of Quality and usiness processes required to assure compliant cGMP (current Good Manufacturing Practices) manufacturing of client's products in either a clinical or commercial setting on time and within budget.. Monitors manufacturing capacities and communicates capabilities to the usiness Leaders and usiness Development for future opportunities.. Assures staff has the proper training, skill set, and personal development opportunities to assure their ability to carry out assigned tasks in compliance with HCATS procedures and policy as well as local, federal and global regulations and industry standard.. Assists in the development, execution and monthly tracking and reporting of assigned operational metrics.. Works collaboratively with Quality Assurance, Quality Controls and Regulatory Affairs, Process Development, Global MSAT and usiness Development, to ensure site and corporate goals are met.. Develops and implements a continual Audit of the site for GMP, Safety, good housekeeping and compliance.. Support EHS (Environmental, Health, and Safety) Manager to assure environmental and OSHA (Occupational Safety and Health Administration) compliance by developing appropriate safety, compliance, quality, and other relevant policies, procedures, goals and metrics.. Accountable for ensuring the assigned plant consistently meets all cGMP and other regulatory requirements.. Assures operations area is kept in a cGMP state of repair through coordination of preventive maintenance and cleaning activities with the Facilities department.. Develops site recapitalization plan to ensure the site operations is stable and profitable.. Responsible for ongoing development and improvement of the infrastructure necessary for the assigned plant to effectively and efficiently deliver against its vision, strategy, plans and objectives.. uilds a world-class team, develops talent and ensures a robust succession plan is in place, at all times for key positions in the plant. Develops a continuous improvement culture within the team.. Drives and oversees regular and ad hoc risk assessment and mitigation planning and management.. Leads and/or participates in various cross-functional teams or committees, e.g. Quality Task Force, S&OP (Sales and Operations Planning), Revenue & Resource.. Develops and executes plans to meet or exceed manufacturing efficiency targets for clients.. Interfaces with senior managers, peers and direct reports to maintain mutual understanding of product design needs, regulatory and production requirements.. Works closely with internal and external colleagues on projects of existing and new products to ensure appropriate capacity, improve quality, adequate sourcing of critical components.. Works to assure annual revenue targets are met by overseeing financial responsibilities which are within the positions control such as staffing, line item expense, capital requirements, capacity utilization.. Support MSAT Process Development, Product Stewardship and Manufacturing Support groups to ensure smooth tech transfer of new products.. Responsible for the initiation and deployment of site process improvement objectives and build the foundations to drive continuous, sustainable, flawless execution and performance through the application of operational excellence principles. We offer consulting services for the implementation and optimization of:. Rapid-Deployment Solutions (RDS). SAP Managed Cloud as a Servic... Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.