Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary:

• Ensuring compliance to Product release/ Labelling process followed at Vantive controlled warehouse
• Ensure implementation and control of product complaints management for products sold in the Korea market
• Maintain a strong relationship with the country business leaders at country level and other support functions.

Essential Duties and Responsibilities:

Manages and leads the day-to-day activities of the Korea QA team:

• Actively participate in the design, implementation and/or maintenance of the quality processes in Korea organization: a) Ensure implementation and control of the QMS for the customer care and field organizations. b) Develop and ensure the implementation of the specific SOPs and protocols applicable to MFDS requirements in alignment with global standards and under the direction of Head of RAQA.
• Perform and administer quality related activities for Korea General Office (GO) as well as perform the product release of Drugs and Devices.
• Design, create, implement and ensure quality assurance of the processes and service provided by distributors, contractors and third parties.
• Keep oversight and lead or actively participate to Korea QA, and other projects in alignment with the Head of RAQA.
• Lead and manage Korea based QA staff.
• Work closely with RA within RAQA team, and closely with BU, fulfilment, Planning and other functions as QA partner.
• Manage quality related activities for Warehousing, Distribution, local labelling, complaints/adverse events management, Field action, etc.
• Responsible for managing suppliers(for example, 3rd party labs) from an operational quality oversight perspective with the support from APAC supplier quality function.
• Perform and train employees on QMS Systems as required for country level operations.
• Ensure annual oversea manufacturers’ GMP license renew in place and implement timely.
• Maintain GMP/Good warehousing practices and any other Quality System rectifications required as per MFDS regulations and corporate requirements
• Provide people leadership in providing leadership direction during the daily work, willing to coach/develop team members’ technical skills and leadership skills.
• Support team members’ development in Korea QA team.

Qualifications:

• 8-10 years healthcare industry Quality assurance working experiences is required. Pharmaceutical experience is essential. Knowledge of applicable regulations (e.g. GMP, Korea pharmaceutical & Device Laws)
• Has a passion for continuously improving the organization
• Ability to manage team in an international environment
• Minimum of 3 years’ experience directly managing teams. Demonstrated success in effectively leading and developing teams.
• Must have a Written and verbal communication skills in Korean & English
• Stays confident when challenged, stating the rationale for one’s viewpoint clearly while listening to and respecting others right to different opinions
• Interpersonal Skills & Influence Adapts communication style to the audience to be heard
• Demonstrates organizational awareness and experience working on cross functional teams and in developing collaborative relationships with other teams and individuals

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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