Compliance coordinator

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:

The Compliance Coordinator supports the execution of Vantive’s Internal Audit and Compliance Strategy Program by coordinating and facilitating key compliance activities.

Responsibilities include data collection and analysis from various IT systems, coordination of external audit activities, administration of the TrackWise 9 system, and participation in assigned compliance and continuous improvement projects

Essential Duties and Responsibilities:

Support data analytics gathering from internal IT tools for routine KPI calculation or linked to special projects

Coordinate collection of external audit notifications and reports, and support risk assessment preparation for the different audits

Participate to special improvement projects to simplify or improve Global Compliance processes (e.g training requirements review)

Act as TW9 administrator for Global Corporate Compliance team

Execute queries/export of data from Trackwise, various format (xls, PDF, word..)

Maintain and generate new instances of Vantive audit custom tool

Support uploading of data to other quality compliance IT tools

Monitor external  audit Activity records target date to ensure timely closure

Maintain the Compliance webpages upon content provided from the team

Define simplification and improvement opportunities among different compliance processes

Coordinate monitoring of budgeted expenses for consultants and services

Qualifications:

Working knowledge of quality system software (e.g. Trackwise and TCU)

Good working knowledge of Windows based applications (e.g. Word, Excel, PowerPoint)

Good working knowledge of MS access databases and Sharepoint management•

Preciseness and attention to details

High level knowledge and understanding of Quality and Compliance principles in the Pharmaceuticals or Medical Device environment: preferred previous experience in Quality or IT for Quality environment

Demonstrable multitasking, project management, and execution skills

Excellent verbal and written communication skills

• Technical, analytical, judgment and problem-solving mindset

• Ability to be self-motivated and work independently within defined timelines

 Education and/or Experience:

A degree in life-science or Engineering, Pharmacy, or equivalent degree in the scientific field                                         

3 years industry experience in Pharmaceutical or Medical device related industry.   

Good  level of English (Spoken, Read, Written). Other languages are also considered an asset.                               

Quality System processes knowledge

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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