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Senior Manager, Quality Operations

Company: The American College of Radiation Oncology
Location: Sunnyvale
Posted on: April 9, 2021

Job Description:

Description The Senior Manager, Quality Operations provides management for the Quality Control and Quality Assurance teams to support the testing and releases of in-vitro diagnostics targeting infectious diseases and oncology. The individual will provide guidance to lab personnel for testing of raw materials, control materials and assays for product qualification and release. The individual will select, develop, and evaluate personnel to ensure the efficient operation of the Quality Control function. Performs activities in concordance with 21CFR Part 820 Quality System Regulations and all Cepheid and Danaher policies.

ESSENTIAL JOB RESPONSIBILITIES:

  • Manages the Quality Control personnel and laboratory operations to support the testing and qualification of raw materials and commercial product
  • Responsible for the hiring, training, and development of Quality Control personnel
  • Develop and maintain Quality Control metrics to assess department and product performance
  • Develop and maintain the Quality Control system to track control materials and retains. Assure material stability and troubleshoot material issues as necessary
  • Maintains continuous alignment of Quality Control operations with strategic business and Quality objectives and possesses advanced skills in leadership, communication, influence, cross-cultural awareness, negotiation, and conflict resolution
  • Works cross-functionally and consults frequently with Manufacturing, Supply Chain, Engineering, Research and Development, Quality Assurance, and Product Transfer, in addition to other functional groups
  • Routinely communicates project goals, status, requirements, and deliverables to Quality Management

    TRAINING RESPONSIBILITIES:
    • Complete all assigned and required training satisfactorily and on time
    • For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time

      MINIMUM REQUIREMENTS:

      Education and Experience:
      • Bachelor's Degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of9+ years related laboratory experience OR
      • Master's degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 7+ years related laboratory experience
      • 4+ years of Supervisory or Department Lead experience managing a technical laboratory team in both processes and resources
      • Medical Device of Life Science industry experience, preferably IVD

        Knowledge and skills:
        • Expert knowledge of US FDA and ISO requirements
        • Exceptionally strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity
        • Extremely detail-oriented with strong organizational skills and high Quality standards
        • Develop strategic goals and objectives from knowledge base and understanding of a customer's business
        • Manage changing conditions, processes and approaches, lead organizations through change effectively
        • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals
        • Track record of measurable, operational improvements to Quality Systems related functions
        • DBS, LEAN or Six Sigma operational excellence training or certification

          PREFERRED REQUIREMENTS:
          • Seven years of Department Leadership experience in managing both processes and resources.
          • Training and certificates in quality or regulatory affairs (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
          • Experience in Quality Control Laboratory Operations
          • Experience in Manufacturing Operations
          • Experience with molecular diagnostics
          • Experience managing both Direct and Indirect labor

            The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

            #LS-JS5

            Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here .

            Job Information
            • Job ID: 56223716
            • Location:
              Sunnyvale, California, United States
            • Position Title: Senior Manager, Quality Operations 2001 6th Ave, Suite 2700 Seattle, Washington 98121 (206) 956-3650

Keywords: The American College of Radiation Oncology, Sunnyvale , Senior Manager, Quality Operations, Executive , Sunnyvale, California

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