Senior Quality Manager

Illumina Inc   •  

Madison, WI

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 49 days ago

Position Summary:

This position is responsible for developing and leading teams dedicated to Manufacturing Quality Engineering. This position is accountable for effectively leading teams, driving change, establishing sustainable business processes, improving products, and providing management with actionable business and product data. This position will serve as a leadership and technical resource to improve quality, reliability, and process capability. The position requires exceptionally strong communication, interpersonal and project management skills to effectively coordinate activities and deliver results cross-functionally. The position is responsible for providing training, guidance and support to drive improvements in all aspects of quality assurance, productivity, and cost reduction. They will select, initiate, and drive improvement projects and serve as a critical resource to foster the use of lean and problem solving tools within the quality assurance team.

Responsibilities:

  • Leads organizational management of a team of dedicated Quality Engineers for enzyme manufacturing, testing; and release activities
  • Develop, implement, and monitor functional area strategic goals, schedules and project plans
  • Responsible for hiring, staffing plan, and budget activities for assigned areas
  • Grows talent within the organization by leading employee development initiatives
  • Drives continuous improvement initiatives to advance quality processes and capabilities
  • Advocates strategically and operationally effective solutions to complex problems
  • Contributes quality and compliance expertise and guidance to teams responsible for addressing specific quality issues
  • Establishes and monitors process metrics and develops action plans as needed
  • Works with business process owners to identify and implement solutions to track and action quality KPIs
  • Leads or provides subject matter expertise during internal and external quality system audits
  • Leads or represents functional area in Site Management Review and Quality Review processes
  • Leads or represents functional area in Material Review Board and CAPA Review Board
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
  • Establishes and supports best practices for problem solving, root cause analysis, and solution selection tools

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

  • Experience implementing and sustaining Quality Management Systems compliant with Federal and other regulations, e.g. QSRs, ISO13485, CMDR
  • Minimum 5-7 years of experience in managing people/resources effectively to accomplish established goals
  • 10+ years of experience in quality engineering in a regulated environment (FDA, ISO13485); direct experience working in in-vitro diagnostic manufacturing preferred
  • Continuous improvement leadership experienceapplying the elements of lean/operational excellence
  • Experience in implementing and leveraging metrics
  • Adaptable to fast-paced, dynamic work environment and shifting demands
  • Ability to work in a matrix organization
  • Extremely strong communication, interpersonal skills and customer focus
  • Strong leadership skills with demonstrated ability to effectively work across teams and functions
  • Proven capacity to effectively manage and escalate risk
  • Demonstrated success in a position requiring highly effective communication, facilitation and negotiation skills
  • Must be open minded, collaborative and able to work in a non-hierarchical environment
  • Must be able to look at processes high level as well as zoom in on a detailed level
  • Project management skills preferred
  • Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CQA, RAC)
  • Green Belt Six Sigma or equivalent credentials in operational excellence preferred

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Education:

  • Bachelor’s degree in an engineering, scientific discipline or equivalent
  • Graduate degree in an engineering or scientific discipline and/or business strongly preferred
    17144-JOB