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

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you 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:

• Plan and monitor quality activities for Clinical Trials, including all phases of clinical trials and post-market clinical studies

• Conduct sponsor clinical sites and vendor assessments as required

• Lead internal and/or regulatory audits of Clinical Trials and/or Clinical Operations

• Handle clinical escalations, non-conformances, or CAPAs related to Clinical Trial operations and/or Clinical vendors

• Manage New Supplier Request process for Clinical vendors

• Consult and approve risk-based approaches developed by Clinical Leadership for human clinical research sponsored by Baxter

• Assess impact of Field Actions on ongoing or planned clinical trials

Regulatory Compliance:

• Interpret clinical regulations and provide guidance to Clinical Operations

• Ensure compliance with regulatory requirements, including GCP, FDA & EMEA regulations, and other relevant standards

• Serve as an interface for inspections, audits, and inspections relating to GCP compliance

Quality Metrics and Risk Management:

• Assist in collecting quality metrics for adequate study oversight

• Identify and assess regulatory and quality risks in activities and processes as necessary according to regulatory agency rules and guidelines and Baxter quality practices

Process Improvements and Initiatives:

• Drive process improvements and initiatives in support of continuous process improvements

• Maintain current and leading-edge expertise in quality management systems and quality techniques

• Stay up-to-date with related quality legislation and compliance around clinical trials

• Travel to regulatory agencies, industry conferences, and other external meetings as required (not expected to exceed 25%)

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 provid