Compliance Lead

9 godzin temu

Warszawa, Mazovia, Polska Baxter Pełny etat
Compliance Lead Job Description

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

Key Responsibilities:
  • Perform Quality Management System (QMS) compliance audits as a team member and/or lead as required
  • Interact with all levels of internal Management across functions and business units
  • Communicate results of audits and internal control evaluations in reports and presentations
  • Evaluate audit responses for adequacy, including root cause, timeliness, and use knowledge to facilitate appropriate corrective action
  • Resolve complex issues and raise concerns through business and Quality Management
  • Serve as a cGMP consultant/subject matter expert and provide researched and supported opinions to complex compliance issues
  • Participate in and/or support preparation of regulatory agency inspections and/or responses to external observations
  • Maintain all organizational and professional ethical standards, while actively advocating and monitoring compliance
  • Actively support continuous improvement of the audit program and Compliance strategy
  • Participate 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
  • Act as a mentor/coach to guest auditors and new hires
Requirements:
  • 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 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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