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 arises

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 applies knowledge to facilitate appropriate corrective action

Resolves complex issues and raises concerns through business and Quality Management

Serves as а 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 monitoring compliance

Actively supports continuous improvement of the audit program and Global Compliance

Participates in special projects/investigations as needed

Acts as а mentor/coach to guest auditors and new hires

We are looking for someone who:

Thorough knowledge of applicable Global regulations and standard

Demonstrable multitasking, project management, and execution skills

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 establish relationships across functional boundaries at multiple levels internally /externally

Ability to independently make quick, sound decisions with limited data and implement appropriate judgment on when to escalate information

Ability to be self-motivated and work independently within defined timelines

Working knowledge of quality system software (e.g. Trackwise)

Education and/or Experience.

Bachelor's Degree (Science or Engineering preferred)

Microbiology background desirable

Minimum оf 7+ years оf experience in Quality, Compliance, Manufacturing, Engineering or related field - with 5+ years of management experience preferred

Past experience as an FDA Inspector desirable

Independent Certifications desired (e.g. CQA, RAPS)

What are some of the benefits of working at Baxter?

Competitive total compensation package

Professional development opportunities

High importance is placed on work-life balance

Commitment to growing and developing an inclusive and diverse workforce

If you are interested in learning more about the prospect of the above role, please apply here so we can discuss it with you in more detail.

For further information, get in touch with sebastian_lange@baxter.com

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.

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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.

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