at Baxter Healthcare Corporation in Deerfield, Illinois, United States
Job Description
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, utilizing 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 proficiencies. This role will require travel for audits. Travel may also be required for inspection support and compliance visits
Performs Quality Management System (QMS) compliance audits as 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 utilizes knowledge to facilitate appropriate corrective action
Resolves complex issues and escalates concerns through business and Quality Management
Serves as 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 supervising compliance
Actively supports continuous improvement of the audit program and Compliance strategy
Participates in special projects/investigations as needed
Lead compliance activities such as best practice 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 mentor/coach to guest auditors and new hires
What you'll bring:
Detailed knowledge of applicable Global regulations and standards
Minimum 5 years experience in auditing or Site Quality Leading experience in drugs or medical device company
Proven 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 execute appropriate judgment on when to escalate information
Ability to be self-motivated and work independently within defined timelines
Proven understanding of quality system software (e.g. Trackwise)
Good proven understanding of Windows based applications (e.g. Word, Excel, PowerPoint)
Baxter is committed to supporting the needs 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.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we... For full info follow application link.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
