QA Compliance lead - Global Auditor
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:
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 visitsPerforms Quality Management System (QMS) compliance audits as 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 utilizes knowledge to facilitate appropriate corrective actionResolves complex issues and escalates concerns through business and Quality ManagementServes as 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 supervising complianceActively supports continuous improvement of the audit program and Compliance strategyParticipates in special projects/investigations as neededLead compliance activities such as best practice 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 mentor/coach to guest auditors and new hiresWhat you'll bring:
Detailed knowledge of applicable Global regulations and standardsMinimum 5 years experience in auditing or Site Quality Leading experience in drugs or medical device companyProven 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 execute appropriate judgment on when to escalate informationAbility to be self-motivated and work independently within defined timelinesProven 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 strive to be more transparent with our pay practices.
The estimated base salary for this position is $128,000 to $176,000 annually.
The estimated range is meant to reflect an anticipated salary range for the position.
We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change.
Individual pay is based on upon location, skills and expertise, experience, and other relevant factors.
This position may also be eligible for discretionary bonuses, and/or long-term incentive.
For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
#LI-BAXGENThe successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment OpportunityBaxter 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 SupplementPay Transparency PolicyReasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
To learn how you can protect yourself, review our Recruitment Fraud Notice.
SummaryLocation:
Deerfield, IllinoisType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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:
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 visitsPerforms Quality Management System (QMS) compliance audits as 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 utilizes knowledge to facilitate appropriate corrective actionResolves complex issues and escalates concerns through business and Quality ManagementServes as 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 supervising complianceActively supports continuous improvement of the audit program and Compliance strategyParticipates in special projects/investigations as neededLead compliance activities such as best practice 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 mentor/coach to guest auditors and new hiresWhat you'll bring:
Detailed knowledge of applicable Global regulations and standardsMinimum 5 years experience in auditing or Site Quality Leading experience in drugs or medical device companyProven 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 execute appropriate judgment on when to escalate informationAbility to be self-motivated and work independently within defined timelinesProven 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 strive to be more transparent with our pay practices.
The estimated base salary for this position is $128,000 to $176,000 annually.
The estimated range is meant to reflect an anticipated salary range for the position.
We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change.
Individual pay is based on upon location, skills and expertise, experience, and other relevant factors.
This position may also be eligible for discretionary bonuses, and/or long-term incentive.
For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
#LI-BAXGENThe successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment OpportunityBaxter 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 SupplementPay Transparency PolicyReasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
To learn how you can protect yourself, review our Recruitment Fraud Notice.
SummaryLocation:
Deerfield, IllinoisType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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