Overview
This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
-
Support for Parents
-
Continuing Education/
Professional Development -
Employee Health &
Well-Being Benefits -
Paid Time Off
-
2 Days a Year to Volunteer
Success Profile
What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Detail Oriented
- Continuous Learner
- Courageous
- Collaborative
- Critical Thinker
- Influential
Sr. Corporate Quality Auditor
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.
Summary:
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, utilizing expertise, knowledge and experience of best-practice methodologies and practices in industry.
What you will be doing!
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. Travel may also be required for inspection support
- Performs Quality Management System (QMS) compliance audits as а 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 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
What do you bring!
- Thorough knowledge of applicable Global regulations and standards
- Demonstrable 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
- Working knowledge of quality system software (e.g. Trackwise)
- Good working knowledge of Windows based applications (e.g. Word, Excel, PowerPoint)
Education and/or Experience:
- Bachelor's Degree (Science or Engineering preferred)
- Minimum оf 7+ years оf experience in Quality, Compliance, Manufacturing, Engineering or related field
- 5+ years of management experience preferred
- Past experience as an FDA Inspector preferred
- Iindependent Certifications desired (e.g. CQA, RAPS)
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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $112,000 to $216,000, plus an annual incentive bonus and equity target. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.
#LI-BAXGEN
#IND-USOPS
#LI-AR1
The 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 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
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.
#LI-Remote
Address
Join Our Talent Community
We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.
Join Now
Find Out More
