Senior QA Lead: Validation & Data Integrity

Baxter International Inc.; Round Lake (IL); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Health insurance

401(k) Retirement Savings Plan

Employee Stock Purchase Plan (ESPP)

Paid holidays and paid time off

Job summary

Baxter International Inc. in Round Lake, IL, is seeking a Senior Quality Assurance professional to lead site validation and data integrity programs, ensure cGMP compliance, and advise cross-functional teams on quality decisions impacting product quality and patient safety.

You will shape validation strategies, govern computerized systems, monitor metrics, and support regulatory inspections, with a focus on continuous improvement and accountability across the site.

Qualifications

• Bachelor’s degree in Engineering, Science, Computer Science, or related field.
• 5+ years in Quality Assurance, validation, computerized systems, data integrity, or related field in pharma/biotech/medical devices.
• Strong knowledge of validation lifecycle management, computerized systems, data integrity, risk management, and regulatory requirements.
• Experience reviewing and approving validation documentation and assessing compliance risks.

Responsibilities

• Provide QA leadership and oversight for complex validation projects with risk-based decisions.
• Review and approve validation documentation (plans, protocols, reports, risk assessments, change controls).
• Partner with R&D, Manufacturing, Engineering, and Quality to support new product introductions and manufacturing readiness.
• Lead Data Integrity Governance Program in line with GAMP 5 and 21 CFR Part 11.
• Establish governance for computerized systems including audit trails and user access reviews.
• Lead investigations and assess impacts of validation or data integrity events on quality and compliance.
• Monitor program performance with metrics; highlight risks to site leadership.
• Support regulatory inspections and audits; present strategy and evidence; drive continuous improvement.

Skills

Quality Assurance leadership

Validation

Data integrity

Regulatory knowledge

Cross-functional collaboration

Investigation

Analytical writing

Regulatory inspections

Education

Bachelor's degree in Engineering, Science, or Computer Science

Job description

Baxter International Inc. in Round Lake, IL, is seeking a Senior Quality Assurance professional to lead site validation and data integrity programs, ensure cGMP compliance, and advise cross-functional teams on quality decisions impacting product quality and patient safety.

You will shape validation strategies, govern computerized systems, monitor metrics, and support regulatory inspections, with a focus on continuous improvement and accountability across the site.