Compliance Lead

1 miesiąc temu

Warsaw, Polska Baxter Pełny etat

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:

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

Minimum 5 years 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)

What do we offer?

Probation period of 3 months and then for an indefinite period.

Competitive salary, annual bonuses, recognition award program.

Corporate culture based on our values: collaboration, speed, courage and simplicity.

Possibilities for development on a personal and professional level in one of the leading global MedTech companies.

Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card.

Bax4U - cafeteria/lunch cards (300 PLN).

PPE program with very attractive conditions available for each employee after 3 months.

Educational support: fully covered language courses (English or other languages according to business needs), financial certifications (ACCA, CIMA)

Co-financing of holidays and an additional 2 days off from work annually.

Employee Stock Purchase Plan.

Great Warsaw office location - Powiśle

Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in person in support of our Mission.

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