Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device (REMOTE)

Senior Manager, Clinical Quality Assurance

At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a jobyou will find purpose and pride.

Your Role at Baxter :

As a skilled Senior Manager, Clinical Quality Assurance, you will lead our clinical quality assurance efforts across Baxter. You will be responsible for proactively anticipating regulatory changes, ensuring compliance with industry best practices, and driving process improvements in clinical trials for all products pharmaceuticals and medical devices. You'll bring a strong understanding of clinical regulations, quality management systems, and industry trends.

What You'll Be Doing :

Clinical Quality Assurance Leadership :

• Independently lead the development and implementation of clinical quality assurance strategies to ensure compliance with regulatory requirements
• Proactively anticipate the horizon of regulations and ensure that current GCP / Clinical Trial practices reflect current and future industry practice
• Provide clinical quality leadership, expertise, and support to Clinical Operations and the CMSO
• Provide subject matter expertise to the MA teams and leadership regarding clinical quality matters with respect to the current regulatory landscape
• Review and approve GQPs involving Human Subjects Research and Human Clinical Research

Quality Assurance Activities :

Regulatory Compliance :

Quality Metrics and Risk Management :

Process Improvements and Initiatives :

Your Team :

As the Senior Manager, Clinical Quality Assurance, you will report directly to the Associate Director, Clinical Operations, Operations & Governance, Worldwide Medical & Regulatory and work collaboratively with cross-functional teams to ensure the delivery of high-quality clinical data and reports.

Your Location :

The role is located at our global corporate headquarters in the greater Chicago, IL area northern suburb of Deerfield. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change. Alternatively candidates residing anywhere in the US will also be considered.

What You'll Bring :

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. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and / or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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.

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 let us know the nature of your request along with your contact information.