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.
Responsibilities:
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.
What You'll do:
* Perform Quality Management System (QMS) compliance audits as a team member and/or lead as needed.
* Interact with all levels of internal management across functions and business units.
* Communicate results of audits and internal control evaluations in reports and presentations.
* Evaluate audit responses for adequacy, including root cause, timeliness, and apply knowledge to facilitate appropriate corrective action.
* Resolve complex issues and raise concerns through business and Quality Management.
* Serve as a cGMP consultant/subject matter expert and provide researched and supported opinions to complex compliance issues.
* Participate in and/or support preparation of regulatory agency inspections and/or responses to external observations as needed.
* Maintain all organizational and professional ethical standards while actively advocating and monitoring compliance.
* Support continuous improvement of the audit program and Global Compliance.
* Participate in special projects/investigations as needed.
* Act as a mentor/coach to guest auditors and new hires.
We are looking for someone who:
* Has thorough knowledge of applicable global regulations and standards.
* Demonstrates multitasking, project management, and execution skills.
* Possesses excellent verbal and written communication skills, including presentation skills.
* Exhibits strong courage of conviction, conflict resolution, interpersonal, and influencing skills.
* Has strong technical, analytical, judgment, and problem-solving skills.
* Can establish relationships across functional boundaries at multiple levels internally/externally.
* Can independently make quick, sound decisions with limited data and implement appropriate judgment on when to escalate information.
* Is self-motivated and can work independently within defined timelines.
* Has working knowledge of quality system software (e.g., Trackwise).
Education and/or Experience:
* Bachelor's Degree (Science or Engineering preferred).
* Microbiology background desirable.
* Minimum of 7+ years of experience in Quality, Compliance, Manufacturing, Engineering, or related field - with 5+ years of management experience preferred.
* Past experience as an FDA/MHRA or other body 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.
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. #J-18808-Ljbffr