Senior QA Lead, Validation & Data Integrity

Regulatory Jobs; Round Lake (IL); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Health and dental coverage

401(k) with company match

ESPP

Paid time off 20–35 days

Parental leave

Commuting benefits

Employee discounts

EAP

Job summary

Baxter is seeking a Senior Quality Assurance professional in the United States to lead validation and data integrity programs, ensuring cGMP compliance and global regulatory expectations. You will partner with cross-functional teams to shape validation strategies, manage governance for computerized systems, and drive continuous improvement.

This role supports regulatory inspections and audits, with accountability for risk-based decision making, program metrics, and a proactive approach to

Qualifications

• Bachelor's degree in a technical field (Engineering, Science, CS or related).
• 5+ years in QA, validation, computerized systems, data integrity in regulated manufacturing.
• Strong knowledge of validation lifecycle management and regulatory requirements.
• Experience reviewing validation docs and assessing compliance risks.
• Proven ability to lead cross-functional initiatives and communicate with all levels.
• Excellent analytical, writing, investigative and decision-making skills.
• Experience supporting regulatory inspections and audit activities.
• Ability to manage multiple priorities with high quality and compliance.
• Must meet site safety and occupational requirements.
• Experience leading data integrity or computerized system governance programs.
• Direct interaction with regulatory agencies during inspections.
• ASQ CQE/CSQE/CQA or equivalent certification.

Responsibilities

• Provide QA leadership for complex validation projects and risk-based decision making.
• Review and approve validation plans, protocols, reports, risk assessments, and change controls.
• Collaborate with R&D, Manufacturing, Engineering, and Quality for new products and readiness.
• Lead Data Integrity Governance Program aligned with regulatory requirements.
• Govern governance processes for computerized systems including access management and audits.
• Lead investigations and assess impact of validation or data integrity events on quality.
• Monitor program performance with metrics and trend analysis; raise risks to leadership.
• Support regulatory inspections and audits with program strategy and evidence.

Skills

Quality Assurance

Validation

Data integrity

Regulatory compliance

Cross-functional leadership

Audits

Communication

Education

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

Tools

GAMP 5

21 CFR Part 11

ALCOA+

Job description

Baxter is seeking a Senior Quality Assurance professional in the United States to lead validation and data integrity programs, ensuring cGMP compliance and global regulatory expectations. You will partner with cross-functional teams to shape validation strategies, manage governance for computerized systems, and drive continuous improvement.

This role supports regulatory inspections and audits, with accountability for risk-based decision making, program metrics, and a proactive approach to