Associate Director, Quality Compliance

Baxter • Round Lake, IL

21h • $152,000 - $209,000

About The Position

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 The Associate Director of Quality Compliance supports the site’s Quality Management System (QMS) and compliance programs across the Round Lake Drug Delivery network. This role provides operational leadership for audits, training, documentation, change control, and inspection readiness activities. The Associate Director partners with the Director of Quality Compliance to ensure the site maintains a robust compliance posture and proactively meets global regulatory expectations. What you'll be doing Compliance Program Leadership Lead day‑to-day activities within the site’s Quality Compliance programs, ensuring alignment with global regulatory requirements. Support implementation of sitewide compliance strategy, policies, and standardization initiatives. Monitor compliance performance and escalate issues to the Director as needed. Inspection Readiness Coordinate readiness assessments and preparation activities for regulatory inspections and corporate audits. Serve as back‑room or front‑room support during inspections; manage documentation and response tracking. Ensure inspection readiness across assigned buildings and shifts. Audit Management Lead internal audits, supplier audits, and follow‑up activities. Support external audit planning, execution, and timely response to findings. Track commitments and ensure effective CAPA implementation. Regulatory Intelligence Implementation Assist in evaluating regulatory updates and enforcement trends. Translate requirements into updated procedures, training, and QMS enhancements. Quality Systems Ownership Oversee controlled documentation processes to ensure accuracy and compliance. Manage training system execution, including curriculum updates, effectiveness checks, and digital training tools. Lead change control processes within delegated authority and contribute to site Management Review preparation. Support digital transformation and compliance‑related modernizations. Remediation & Risk Management Lead or support remediation teams focused on resolving compliance gaps and audit findings. Conduct risk assessments and monitor compliance KPIs, dashboards, and analytics. Identify systemic issues and partner cross‑functionally for sustainable solutions. Cross‑Functional Collaboration Work closely with QA Ops, Engineering, Manufacturing, Facilities, Supply Chain, and Regulatory Affairs. Support compliance aspects of tech transfers, submissions, capital projects, and lifecycle changes. People Leadership Manage and develop Quality Compliance staff. Build a culture of transparency, engagement, and continuous improvement.

Requirements

• Bachelor’s degree in science or engineering required; advanced degree preferred.
• 10+ years of experience in Quality Compliance/Quality Systems; 3–5 years leadership.
• Recent pharmaceutical manufacturing experience is required.
• Strong knowledge of FDA/EMA regulations, QMS elements, and audit/inspection processes.
• Proven ability to lead audits, manage documentation systems, and drive compliance imp rovements

Responsibilities

• Lead day‑to-day activities within the site’s Quality Compliance programs, ensuring alignment with global regulatory requirements.
• Support implementation of sitewide compliance strategy, policies, and standardization initiatives.
• Monitor compliance performance and escalate issues to the Director as needed.
• Coordinate readiness assessments and preparation activities for regulatory inspections and corporate audits.
• Serve as back‑room or front‑room support during inspections; manage documentation and response tracking.
• Ensure inspection readiness across assigned buildings and shifts.
• Lead internal audits, supplier audits, and follow‑up activities.
• Support external audit planning, execution, and timely response to findings.
• Track commitments and ensure effective CAPA implementation.
• Assist in evaluating regulatory updates and enforcement trends.
• Translate requirements into updated procedures, training, and QMS enhancements.
• Oversee controlled documentation processes to ensure accuracy and compliance.
• Manage training system execution, including curriculum updates, effectiveness checks, and digital training tools.
• Lead change control processes within delegated authority and contribute to site Management Review preparation.
• Support digital transformation and compliance‑related modernizations.
• Lead or support remediation teams focused on resolving compliance gaps and audit findings.
• Conduct risk assessments and monitor compliance KPIs, dashboards, and analytics.
• Identify systemic issues and partner cross‑functionally for sustainable solutions.
• Work closely with QA Ops, Engineering, Manufacturing, Facilities, Supply Chain, and Regulatory Affairs.
• Support compliance aspects of tech transfers, submissions, capital projects, and lifecycle changes.
• Manage and develop Quality Compliance staff.
• Build a culture of transparency, engagement, and continuous improvement.

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees