Compliance Lead

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Summary

We are looking for a Compliance Manager responsible for supporting Baxter's Kidney Care Segment Internal Audit and Compliance Strategy program:

Ensure compliance to company policies / regulations and standards globally. Collaborate cross-functionally within Baxter's Kidney Care Segment functions/businesses. Grow the auditing capability within Quality Assurance, applying expertise, knowledge and experience of best-practice methodologies and practices in industry.

What you'll be doing

To succeed in this role, the candidate should have extensive auditing and/ or compliance leading experience drug and/or medical device competencies. This role can be home-based but will require travel for audits. Travel may also be required for inspection support and compliance visits

• Performs Quality Management System (QMS) compliance audits as а team member and/or lead as required

• Interacts with all levels of internal Management across functions and business units

• Communicates results of audits and internal control evaluations in reports and presentations

• Evaluates audit responses for adequacy, including root cause, timeliness as well as uses knowledge to facilitate appropriate corrective action

• Resolves complex issues and raises concerns through business and Quality Management

• Serves as а cGMP consultant/subject matter expert and provides researched and supported opinions to complex compliance issues

• As needed, participates in and/or supports preparation of regulatory agency inspections and/or responses to external observations

• Maintains all organizational and professional ethical standards, while actively advocating and monitoring compliance

• Actively supports continuous improvement of the audit program and Compliance strategy

• Participates in special projects/investigations as needed

• Lead compliance activities such as standard process sharing, leading QA councils for manufacturing plants and other quality improvement initiatives

• Lead or participate in Audit Program Management and audit risk calculation strategy

• Lead or participate in Site Risk Program management and drive improvements 

• Acts as а mentor/coach to guest auditors and new hires

What you'll bring

• Thorough knowledge of applicable Global regulations and standards

• Proven experience in auditing or Site Quality Leading experience in drugs or medical device company

• Demonstrable multitasking, project management, and execution skills

• Must be willing to travel up to 50% both domestically and internationally

• Excellent verbal and written communication skills, including presentation skills

• Strong courage of conviction, conflict resolution, interpersonal and influencing skills

• Strong technical, analytical, judgment and problem-solving skills

• Ability to build relationships across functional boundaries at multiple levels internally /externally

• Ability to independently make quick, sound decisions with limited data and complete appropriate judgment on when to increase information

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

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

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

Reasonable Accommodations

Baxter 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.

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