Compliance Lead

Vantive: A New Company Built On Our LegacyBaxter 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.SummaryWe 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 visitsPerforms Quality Management System (QMS) compliance audits as а team member and/or lead as requiredInteracts with all levels of internal Management across functions and business unitsCommunicates results of audits and internal control evaluations in reports and presentationsEvaluates audit responses for adequacy, including root cause, timeliness as well as uses knowledge to facilitate appropriate corrective actionResolves complex issues and raises concerns through business and Quality ManagementServes as а cGMP consultant/subject matter expert and provides researched and supported opinions to complex compliance issuesAs needed, participates in and/or supports preparation of regulatory agency inspections and/or responses to external observationsMaintains all organizational and professional ethical standards, while actively advocating and monitoring complianceActively supports continuous improvement of the audit program and Compliance strategyParticipates in special projects/investigations as neededLead compliance activities such as standard process sharing, leading QA councils for manufacturing plants and other quality improvement initiativesLead or participate in Audit Program Management and audit risk calculation strategyLead or participate in Site Risk Program management and drive improvements Acts as а mentor/coach to guest auditors and new hiresWhat you'll bring:Thorough knowledge of applicable Global regulations and standardsMinimum 5 years experience in auditing or Site Quality Leading experience in drugs or medical device companyDemonstrable multitasking, project management, and execution skillsMust be willing to travel up to 50% both domestically and internationallyExcellent verbal and written communication skills, including presentation skillsStrong courage of conviction, conflict resolution, interpersonal and influencing skillsStrong technical, analytical, judgment and problem-solving skillsAbility to build relationships across functional boundaries at multiple levels internally /externallyAbility to independently make quick, sound decisions with limited data and complete appropriate judgment on when to increase informationAbility to be self-motivated and work independently within defined timelinesWorking 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.