ROCHE HOLDINGS INC Head of Operations Sequencing in MADISON, Wisconsin

JOB REQUIREMENTS: Plan, direct and manages a multi-disciplinary team engaged in all day-to-day aspects of Operations Management, such as production planning and scheduling, purchase of raw materials, manufacture and QC of product, disposition of non-conforming material and approval of scrap. Implement programs and strategies to meet or exceed annual improvement targets for product quality, availability and cost. Establish, monitor and report on key performance indictors in pursuit of same manufacturing of materials for products. Directs activities of sub-teams responsible for scheduling project priorities, product testing, troubleshooting, and validation. Assumes responsibility for resource deployment, and establishment of appropriate staffing levels and expenditures to meet overall departmental objectives. Leads implementation/maintenance of QSR/ISO elements and adoption of state-of-the art techniques. Hire and develop exceptional talent in order to establish a high-energy, high-achievement culture committed to continuous improvement and business success * Ensure organizational compliance to Madison Quality Management System (QMS) Ensure adequate quality and cost controls are in place to achieve objectives. Oversees deployment of available resources to meet required production demands. Monitors inventory levels and weekly production schedules. Interacts with project teams on tech team specific issues involved with characterization process and establishes plan to meet all production requirements (routine and new product launches) and departmental objectives. Develops and monitors timelines and activities related to team projects, including but not limited to troubleshooting, process and scale validation, feasibility studies, etc. Assures timely completion of all production related activities including but not limited to record review (batch, packaging, filling) and investigation reports. Participates in planning and resource allocation for operational validation programs to qualify new processes or equipment (in-house or at subcontractor sites). May oversee some development activities or be actively involved in sub-contractor oversight. Oversee the transition from current building to new building including validation requirements under tight timelines in a compliant manner. Performs delegated management functions, including performance management, providing training and development opportunities for staff, assuring a climate of equal employment opportunity, and promoting the achievement of affirmative action goals. Prepares, recommends, and implements operating and capital budgets. Manages resources to achieve desired results in the most time and cost effective manner. Participates in active direction of production investigations and data summarization; ensures CAPA's are completed in appropriate timeframes. Provides senior management with timely input on operational issues, including new product transfers, project updates, personnel status, etc. Monitors compliance with safety regulations (NRC, OSHA, EPA, local and state and regulatory agencies, etc.), ensuring adequate training is provided for staff. Coordinates planning/execution of standardized operating procedures across sub-teams and sub-contractors. Develop, implement, and monitor long term (yearly) goals, schedules and production plans. Setting business goals and cross-functional deliverables. Design, develop, implement and ensure adherence to compliance, which includes improvements to current programs and training all staff members on programs. Represent manufacturing operations in defining and refining validation strategy, investigations and technical transfers. Develop, implement and oversee the administration of a budget, which includes equipment, materials, and staffing. Identify employee training and developmental needs and effectively mentor, support and counsel staff to ensure optimal performance, productivity, and competency. ***** OTHER EXPERIENCE AND QUALIFICATIONS: Must have expert knowledge of Sequencing Capture and Custom Biotech application standards, a proven track record of leading compliant operations through successful ISO 13485 Audits. Must have demonstrated the ability to drive quality and productivity improvements, have a credible, highly regarded reputation in the biopharmaceutical industry, and strong management and leadership capabilities. Experience in reagent production and project management is preferred. ***** APPLICATION INSTRUCTIONS: Apply Online: