Compliance Lead

4 tygodni temu

Warszawa, Mazovia, Polska Baxter Pełny etat

Visionary Compliance Leadership

Baxter is revolutionizing kidney care and other vital organ support, and we're seeking a visionary Compliance Lead to join our team. As a key member of our Internal Audit and Compliance Strategy program, you will be responsible for ensuring the highest standards of compliance and regulatory adherence across our Kidney Care Segment.

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 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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