Sr Spec, Quality Assurance

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.

The Quality Assurance Specialist is responsible for supporting and maintaining quality and regulatory compliance for pharmaceutical and medical device operations in Korea by performing the duties and responsibilities outlined below.

Responsible for preparation of Documentation for release of Drug & PD Medical Device.

• Perform and manage product release, labeling processes for pharmaceuticals and medical devices, and the product hold system.
• Lead and manage analytical method transfers and local testing activities for pharmaceuticals in Korea.
• Perform and manage field actions, including communication with internal and external stakeholders and timely reporting to the Ministry of Food and Drug Safety (MFDS).
• Perform and manage product complaint handling activities for products marketed in Korea and provide complaint and vigilance training to employees.
• Ensure timely post-market reporting of medical device adverse events to the MFDS.
• Conduct gap analyses of global and APAC regional quality documents and requirements.
• Manage and maintain local quality documents, including SOPs, manuals, APQRs, and product master files.
• Maintain pharmaceutical and medical device business licenses and KGMP certifications, and prepare related documentation.
• Perform QMS activities and other quality-related responsibilities for the Korea General Office (GO), and support internal, external, and regulatory audits.
• Perform and manage change control activities.
• Support local training programs and monitor training compliance in Korea.
• Perform quality-related activities for warehousing operations and ensure the quality of services and processes provided by 3PL providers, distributors, contractors, and other third parties.
• Support the maintenance of GMP and Good Warehousing Practices (GWP), and implement quality system improvements in accordance with MFDS regulations and corporate requirements.
• Collaborate closely with Regulatory Affairs (RA) within the RAQA team, as well as with Business Units, Fulfillment, Planning, and other cross-functional teams

Qualifications:

• 5–10 years of Quality Assurance experience in the healthcare industry is required. Pharmaceutical industry experience is essential.
• Knowledge of applicable regulations and standards, including GMP and Korean pharmaceutical and medical device regulations.
• Strong written and verbal communication skills in both Korean and English.
• Demonstrates confidence when challenged, clearly articulating the rationale for own viewpoints while listening to and respecting differing opinions.
• Strong interpersonal and influencing skills, with the ability to adapt communication styles to different audiences to ensure effective collaboration.
• Demonstrates organizational awareness and experience working in cross-functional teams, with a proven ability to build and maintain collaborative relationships across functions and with key stakeholders.

Education and/or Experience:

• Bachelor's degree is required, preferably in a scientific discipline, Business Administration, Industrial Engineering, or a related field.
• A minimum of 5 years of experience in pharmaceutical and/or medical device GMP/QSR quality management is required.
• An advanced degree is preferred.

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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