Senior Quality Assurance Lead - QMS & Investigations

Regulatory Jobs; Round Lake (IL); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

Baxter is seeking a Quality Associate III to drive senior-level oversight of Quality Management System processes and lead complex investigations. You will collaborate with cross-functional teams to ensure inspection readiness, data integrity, and timely resolution of quality issues.

You will provide coaching on QMS practices, maintain inspection-ready records in eQMS, and support regulatory inspections while focusing on safe, high-quality products for patients.

Qualifications

• Bachelor’s degree in science, engineering, pharmacy, life sciences, quality, regulatory affairs, or a related technical discipline.
• 4+ years of experience in Quality Assurance, Quality Systems, or related regulatory roles.
• Experience with QMS elements (change control, CAPA, complaints, NCR, deviations) and inspection readiness.

Responsabilités

• Own or provide senior-level oversight for Quality Management System processes including change control, CAPA, complaints, nonconformance records, and metrics.
• Serve as site SME for QMS processes: routing, impact assessment, implementation planning, closure quality, inspection readiness.
• Lead or support complex quality investigations: root cause analysis, corrective/preventive actions, effectiveness verification.
• Assess proposed changes for regulatory impact, product quality, patient safety, data integrity, and business continuity.
• Prepare, analyze, and report QMS metrics including CAPA timeliness and aging records.
• Develop management-review data packages and dashboards communicating QMS performance and risks.
• Partner cross-functionally to drive timely resolution of quality issues across functions.
• Support internal and regulatory audits by preparing records and responding to requests.
• Provide coaching and training on QMS expectations and documentation quality.

Description du poste

Baxter is seeking a Quality Associate III to drive senior-level oversight of Quality Management System processes and lead complex investigations. You will collaborate with cross-functional teams to ensure inspection readiness, data integrity, and timely resolution of quality issues.

You will provide coaching on QMS practices, maintain inspection-ready records in eQMS, and support regulatory inspections while focusing on safe, high-quality products for patients.