Head of Operations, Sequencing

United States, Wisconsin, Madison

Head of Operations will lead all aspects of Sequence Capture production, including Production Planning, Manufacturing, Quality Control and Manufacturing Engineering. Responsible for setting manufacturing strategies, implementing policies and procedures consistent with the Quality Management System (QMS), developing and mentoring manufacturing employees and driving business results related to product quality, availability and cost. Direct and support Global Operations Manufacturing and business goals in staff development, safety, quality, and compliance, efficiency, continuous improvement, and customer service. As a key member of the Sequencing Operations Leadership Team (SOLT), this role is responsible for leading the successful execution of manufacturing operations in a dual construction production environment. Ensure effective use of resources and control of expenses to achieve maximum productivity; develop and sustain robust scaleable business processes. Responsible for directing, initiating and executing department objectives typically through subordinate managers. Develops and administers budgets, schedules and performance requirements for department.

 

Primary Job Responsibilities:

  • 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. This includes following HR policies and procedures.
  • Proactively determine department needs and communicate these to support groups.
  • Ensure that all operations are performed with 100% compliance with cGMP standards.
  • Ensure maintenance of a safe manufacturing work environment that complies with company and state regulations.
  • All employees with jobs that require access to the Warehouse must be able to pass the local Transportation Security Administration (TSA) or Security Threat Assessment (STA).
  • Engages in proactive measures to promote a positive safety culture to ensure the protection of people, property, and the environment through group communications about SHE aspects at the company, review of SHE performance metrics and incident reports. Participates in incident investigations and CAPAs, conducts monthly work area tours to assess SHE aspects in the work area and orally communicates one on one with employees in their work area to gauge employee issues and concerns. Fosters a positive safety culture in which no one gets hurt.

 

Additional Responsibilities:

  • Leadership of all aspects of Manufacturing operations in pursuit of annual quality, cost and delivery goals
  • Establishment, maintenance and mentoring of a high-performance team and culture within Operations, achieving high levels of continuous improvement, cross functional cooperation and employee engagement
  • Ensure organizational compliance with all Roche ethical and Quality Management standards
  • Leadership of local aspects of corporate, division and Global Operations initiatives and improvement programs, including development and implementation of a local operations strategy consistent with Global Operations strategy and best practices
  • Create and manage a workplace that makes employee health and welfare a priority. Set an example of prioritizing employee safety. Demonstrate compliance with all SHE policies and procedures; establish and maintain a safe work environment for team members. Hold self, team members, and colleagues accountable for complying with SHE policies and procedures. Remain current on SHE training requirements.
  • Promotes a work culture that reinforces compliance with quality and regulatory requirements and emphasizes customer focus.
  • Provides leadership to ensure department objectives and goals are achieved. Manages subordinates (professional and support staff) and assists Director or senior leaders in overall operation of department.
  • Establishes and manages department budget and resources. Has full discretion on all employment decisions for department staff including hiring, training, performance management, and progressive disciplinary actions.
  • Competencies include Business knowledge, technical expertise, strategic agility, results driven, process management, building and leading team, decision making, collaboration and team work, communication, collaboration, developing self and team, and leading innovation and change.

 

Responsible for manufacturing operations in Madison, Wisconsin U.S.A. Position reports to the Vice President, Sequencing Operations.