This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Responsible for supporting Baxter's Corporate Internal Audit program. Ensure compliance to company policies / regulations and standards globally. Collaborate cross-functionally within Baxter’s functions/businesses. Grow the auditing capability within Quality Assurance, applying expertise, knowledge and experience of best-practice methodologies and practices in industry.

To succeed in this role, the candidate should have extensive auditing experience within the drug and medical device competencies. This role can be home-based but will require travel for audits primarily in EMEA / APAC (however there may be some in the US to support colleagues (around 50%). Travel may also be required for inspection support.

What You'll do:

Performs Quality Management System (QMS) compliance audits as a team member and/or lead as the need arisesInteracts 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 applies 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 Global ComplianceParticipates in special projects/investigations as neededActs as а mentor/coach to guest auditors and new hires

We are looking for someone who:

Thorough knowledge of applicable Global regulations and standardDemonstrable multitasking, project management, and execution skillsExcellent 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 establish relationships across functional boundaries at multiple levels internally /externallyAbility to independently make quick, sound decisions with limited data and implement appropriate judgment on when to escalate informationAbility to be self-motivated and work independently within defined timelinesWorking knowledge of quality system software (e.g. Trackwise)

Education and/or Experience.

Bachelor's Degree (Science or Engineering preferred)Microbiology background desirableMinimum оf 7+ years оf experience in Quality, Compliance, Manufacturing, Engineering or related field - with 5+ years of management experience preferredPast experience as an FDA Inspector desirableIndependent Certifications desired (e.g. CQA, RAPS)

What are some of the benefits of working at Baxter?

Competitive total compensation packageProfessional development opportunitiesHigh importance is placed on work-life balanceCommitment to growing and developing an inclusive and diverse workforce

Reasonable Accommodations

Baxter 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 Notice

Baxter 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.

147351