Ortho Clinical Diagnostics

  • QA & RA Manager

    Job Locations KR-11-Yongsan-gu
    Posted Date 2 months ago(13/4/2018 4:12 AM)
    Job Country
    Korea, South
  • 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 QA & RA Manager

    The Responsibilities

    Provide strong support to business growth in South Korea (SK), by ensuring Quality & Regulatory Compliance per regulatory requirement and Ortho policy, and timely escalating any issue/potential issue per Ortho requirement.


    1. Regulatory Compliance

    Full responsible for Ortho SK for compliance with local regulatory requirements, including

    • Communicate and align with line manager, business lead, and other stakeholders on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay;
    • Per regulations in South Korea, leading the QRA specialist, timely register all the regulated products, and maintain the licenses, including new registration, and changes;
      • Communicate for the documentation required and support needed;
      • Review the documents received, prepare local dossiers, and submit to local health authorities;
      • Communicate with health authority for enquiries regarding the registration;
      • File all the licenses/certificates; maintain and regularly update the license list;
    • Update the registration status in SAP system;
    • Develop and/or update the local label/IFU and PMF per the approved license;
    • Lead the Ortho SK certification as well as inspection if it’s required for the certification;
    • Review and approve the promotion materials;
    • Report Adverse Event and Field Corrective Action per local regulation;
    • Review and evaluate the regulatory Changes/Trends, lead the actions to address the changes and minimization the business impact;
    • Escalate any major/critical and urgent regulatory compliance issue in timely manner, whenever applicable;


    1. Quality Compliance
    • Maintain and improve Quality Management System (QMS) in ORTHO SK, to ensure the QMS is running effectively and compliance to Ortho requirement, and the local regulatory requirements;
    • Lead the Quality System Management Review in Ortho SK, to review the QMS, to ensure its continuing suitability, adequacy and effectiveness;
    • Lead the internal audit and external audit, including the audit/inspection by regulatory authority and notify body;
    • Manage NC and stop shipment, including the following
      • Timely restrict/un-restrict Products in SAP system, and inform LSP physical quarantine/release the products with defects and/or under Stop Shipment;
      • Timely coordinate the disposition of non-conforming products, and make the decision on the product return if necessary;
    • Manage CAPA;
    • Manage Change Controls;
    • Quality Training:
      • Working together with function leaders, set up training matrix for all the quality related training, and review it at least once a year;
      • Build up quality improvement capabilities and maintain a quality training system, collaborate with country/function leaders to ensure all employees are well trained prior to performing any assignment from quality perspective;
      • Provide Quality training, including but not limited to Quality SOPs/WIs;
    • Management of all suppliers and distributors, focus on the critical ones, like the 3rd party distribution centers, and 3rd party products suppliers,
      • Qualification and Quality Agreement;
      • Regular Training;
      • Annual Audit and Regular Visit;
      • NC/CAPA review and follow up;
    • Make sure the complaints of Ortho products are reported within 24hrs per requirement;
    • Make sure the Field Corrective Action conducted in SK compliant to the local regulatory requirement and Ortho requirement;
    • Operate as a key business partner for quality and process improvement, understand business requirements and execute quality programs to drive organization capability building.
    • Timely escalate the Quality Compliance Issue per Ortho


    1. Others
    • Compliant with all the applicable regulations and Ortho policy;
    • Reporting Ortho complaints within 24 hours of awareness;
    • Support the business tendering;
    • Monitor the registration cost and routine expense, monthly report the discrepancies against the AOP if any; and supporting the budget planning;


    1. Collaboration & Team Work
    • Collaborate with all country/function leaders for continuously improvement on Quality & regulatory Compliance in Ortho SK;
    • Per business needs, support QA&RA in other countries in ASPAC;
    • Other assignments, whenever necessary.


    The Individual

    Functional Competency

    • Education: Bachelor’s or Master’s degree in Biosciences, Chemistry, Engineering, Pharmacy or equivalent field.
    • Experience:
      • A minimum of 8 years RA&QA experience in healthcare industry; 5-year RA experience in Medical Device or IVD industry is essential.
      • A minimum 1-2 years holding management roles.
      • ISO9001/ISO13485 auditor or lead auditor certification is required.
      • A background in the Cold Chain products is highly preferred.
    • Language: Fluent English speaking, writing, and reading.


    Leadership Competency

    • Strong leadership skills and good team player.
    • Good written and verbal communications skills, good influencing and interpersonal skills, ability to influence and interact at multiple levels of the organization.
    • Good learner and ability to proactively identify improvement opportunities.
    • Ability to manage multiple priorities and deliver excellent results.
    • Fluent in written and spoken English.

    Equal Opportunity

    At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career. 


    Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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