Tech Compliance (Fixed-Term Contract)
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.
We’re grateful you’re interested in continuing your career journey with Vantive. This is where you can do your best work. Where your purpose accelerates our mission.
Summary
We are looking for a Tech, Compliance responsible for supporting Vantive's Kidney Care Segment Internal Audit and Compliance Strategy program:
- Support the enrollment of internal audit program
- Support other Compliance initiatives such as monthly and quarterly compliance working team meetings, document and audit report publication
- Enroll and maintain compliance internal webpage
- Collaborate cross-functionally within Vantive's Kidney Care Segment functions/businesses.
What you'll be doing:
To succeed in this role, the candidate should have quality experience in drug and/or medical device competencies.
- Supports Quality Management System (QMS) compliance audits scheduling
- Prepares results of audits and internal control evaluations in reports and presentations
- Publishes compliance related documents in TcU
- As needed, participates in and/or supports preparation of regulatory agency inspections and/or responses to external observations
- Supports continuous improvement of the audit program and Compliance strategy
- Participates in special projects/investigations as needed
- Supports compliance activities such as best practice sharing, leading QA councils for manufacturing plants and other quality improvement initiatives
- Supports Audit Program Management and audit risk calculation strategy
- Support in Site Risk Program management and drive improvements
What you'll bring:
- Minimum 2 years of experience in quality organization of pharmaceutical/ medical device company
- Experience in auditing or compliance topics is a plus
- Demonstrable multitasking, project management, and execution skills
- Excellent verbal and written communication skills, including presentation skills
- Courage of conviction, conflict resolution, interpersonal and influencing skills
- Technical, analytical, judgment and problem-solving skills are a plus
- Ability to build relationships across functional boundaries at multiple levels internally /externally
- Ability to be self-motivated and work independently within defined timelines
- Working knowledge of quality system software (e.g. Trackwise and TCU)
- Good working knowledge of Windows based applications (e.g. Word, Excel, PowerPoint)
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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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Address
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