Director, Quality Auditing and Compliance Excellence
1 month ago
**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.
- Job Description
**Your Role at Baxter**
**This is where your creativity addresses challenges**
**Your Team at Baxter**:
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.
We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.
**What you'll be doing**:
- Manage the strategy, design and implementation of the Audit Quality System. Oversight of Audit process results and conformance to regulations and Baxter Quality Manual.
- Manages a global team of leaders and auditors that audit Baxter sites, external suppliers, preclinical suppliers and clinical suppliers.
- Understands and assures conformance to regulations. May interface with regulators during regulatory inspections.- Facilitates harmonization of regulatory responses.
- Partner with quality leaders and stakeholders on audit/audit readiness strategy, process and execution.- Business Process Owner of the audit/inspection database.
- Manages overall coaching, training, development, and succession plans for the team.
**What you'll bring**:
- Significant experience (10+ years) in Quality, Regulatory, and/or Manufacturing. 7+ years of management experience.
- Technical experience in drug, biologics, and medical device industry.
- A degree in a life science or engineering discipline is required; an advanced degree is preferred.
- Experience (5+ years) in auditing.
- Experience inspecting manufacturing sites for a global regulator, FDA experience preferred
- Experience leading a large Quality or Regulatory organization; strong ability to motivate and lead a diverse team with varying levels of experience while also collaborating with colleagues across the globe.
- Proven leadership ability with a track record of making difficult decisions in a logical, rational manner.
- Demonstrated ability to work as a leader. Strong communication skills are essential.
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 at **any Baxter location**. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
LI-SL1
**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**
**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.
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