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.

Essential Duties and Responsibilities:

• Perform and handle the QA activities for General office and Technical Service Center, include but not limited to: Product Release, Product Return, Product Recall, Managing Relabeling, 3rd party warehouse management
• Maintain an effective and continuously improved quality management system and in compliance with local regulations: ensure implementation of all processes, tracking quality KPIs.
• Manage and execute field corrective action, COI (certificate of implementation), NCR/ CAPA, change control to ensure the compliance of GMP, GDP standard, company corporate requirements.
• Responsible for product complaints handling
• Liaise with local government authorities and hospitals for quality issues.
• Maintain an effective and continuously improved quality management system and in compliance with local regulations: ensure implementation of all processes, tracking quality KPIs.
• Internal and External Audit management.
• Ensure all necessary local Quality SOPs are in place, reviewed or updated periodically.
• Conduct quality training to colleagues.
• Ensure suppliers adherence to company standards and local regulations, supplier qualification process, participant supplier audit, manage supplier re-evaluation.
• Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups.
• Handle additional projects and tasks assigned

Qualifications:

• Ability to work effectively in multinational/ multicultural environment
• Technical and project management skills
• Quality and regulatory knowledge
• Ability to oversee multiple projects in a matrix team environment
• Excellent oral and written communication and presentation skills
• Good understanding of GxP (Good Practice)

Education and/or Experience:

• Bachelor's degree in pharmacy highly preferable;
• At least 4 years of working experience of QARA in healthcare industry

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.