Ortho Clinical Diagnostics

  • Senior Manager, Site Quality Operations

    Job Locations US-FL-Pompano Beach
    Job ID
    2018-5255
    Job Country
    United States
    Category
    Regulatory & Quality
  • The Company

    Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.

     

    With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.

     

    Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.

     

    Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.

     

    Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

    The Career Potential

    Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.


    Ortho is known in the industry as a leader in customer service and support.  Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do.  It’s who we are.  If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

    The Opportunity

    As the company continues to grow, we are seeking a Senior Manager, Site Quality Operations in Pompano Beach, FL.

     

    This position will be responsible for providing the overall leadership for the Pompano Site Quality Operations Organization focused on ensuring flawless execution against the Quality System to ensure regulatory compliance with Ortho Clinical Diagnostics global policies, international law and guidance.

    The scope of the role includes but is not limited to Raw Material / Component incoming inspection and release, Microbiology, Quality & Validation Engineering, Quality Control and Release Testing, Final Product Release and Site Compliance & Inspection Readiness.

    The Senior Manager is responsible for developing both short term tactical goals and objectives in addition to longer term strategies to drive efficiencies through simplification of Quality processes and procedures while driving continuous improvement in manufacturing quality, product quality and compliance performance. In partnership with the Quality Systems & Compliance Team the position is responsible for the Pompano Beach Site compliance performance balanced with a global responsibility through leading teams in the identification and standardization of best practices to drive both efficiency and compliance excellence.

    As a member of the Quality Operations Leadership Team the role will require close collaboration with the other Site Quality, Product Design Quality & Design Quality leads, in addition to partners within the WW Operations and Supply Chain organizations.

     

     

    The Responsibilities

    • Leadership of the Pompano Beach Site Quality organization ensuring efficient and flawless execution against the Quality System and associated processes to ensure Product Quality and Compliance with Ortho global policies, international law and guidance. Builds overall organizational capability and capacity to meet both the current and future needs of the business through talent acquisition, employee training / development and performance management.
    • Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure that resources are sufficient and projects are appropriately prioritized in alignment with regulatory requirements and business goals. At the site level leads and the global level supports the development of policies and procedures to ensure Product Quality & Regulatory Compliance.
    • Directs day to day Quality Operations activities at the Pompano Beach Site as required to support Operations including Raw Material Inspection & Release, Maintenance of the Site Master Validation Plan, Quality Engineering with oversight for Root Cause Investigation, Product Disposition, Corrective & Preventative Action, Microbiology and Environmental Monitoring, Product Release, Site Compliance & Inspection Readiness. Participates and collaborates with Supply Chain, Facilities, Operation’s Manufacturing and Engineering leaders to identify potential areas of process and product variability, addresses root causes and implement improvements.
    • Utilizes data to assess the overall health and effectiveness of the Quality processes / systems and identification of areas for process improvement. Leads strategy development at the site level and supports at the global level execution of a pipeline of continuous improvement initiatives to drive simplification, reliability and overall effectiveness of Quality processes.
    • Responsible for Annual Operating Plan (AOP) development and overall budgetary oversight for the Pompano Beach Site Quality Operations organization. Partners with Finance and Operations business partners to ensure that expenses, headcount and capital are in alignment with Ortho business goals, financial targets and strategic plans.
    • Holds responsibility for the Quality issue escalation process as chair of the SQIR (Site Quality Issue Review) forum and holds ultimate decision authority for further escalation to the PQR (Product Quality Review) forum.

    The Individual

    • Minimum of a Bachelor’s degree in Science, Engineering, QA, or other related business field. Post graduate degree (MA, MS, MBA of PhD) is preferred.
    • A minimum of 8-10 years’ experience in the Pharmaceutical, Medical Device or Biotech Industry with a strong preference for leadership experience in a functional Quality role.
    • Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
    • Working knowledge of both FDA CDRH and CBER (licensed biologics) Quality Systems Regulations, CMDR and ISO13485 standards is required.
    • Ability to host / manage external Quality System inspections is required with a preference for experience gained within biannual CBER inspections of licensed biologics facilities.
    • Demonstrated knowledge of business impact of compliance issues and risk management is required. Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is a prerequisite. Expert knowledge of Good Manufacturing Practices, all applicable regulations and validation methods is necessary.
    • Up to 10% domestic and/or international travel.
    • Work visa sponsorship is not available for this position.

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    Equal Opportunity

    Ortho Clinical Diagnostics believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com.

     

    Supplemental Poster

     

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