Senior QA & Validation Lead – Data Integrity

Baxter International Inc.; Round Lake (IL); Sur place; USD 96 000 - 132 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental coverage

ESPP

401(k) Retirement Plan

Paid time off

Parental leave

Commuting benefits

Résumé du poste

Baxter International Inc. seeks a Senior Quality Assurance professional to lead site validation and data integrity programs, ensuring cGMP compliance and global regulatory expectations.

You’ll advise cross-functional teams and shape validation strategies to support product quality and patient safety across the site. The role involves governance, risk assessment, and collaboration with R&D, Manufacturing, and Quality teams to enable production readiness and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Science, Computer Science, or a related technical field.
• 5+ years of experience in Quality Assurance, validation, computerized systems, data integrity, or a related field within pharmaceutical, biotechnology, or medical device manufacturing.
• Strong knowledge of validation lifecycle management, computerized systems, data integrity principles, risk management, and applicable regulatory requirements.
• Experience reviewing and approving validation documentation and assessing compliance risks within regulated environments.
• Proven ability to lead cross-functional initiatives, influence team members, and communicate effectively with all levels of the organization.

Responsabilités

• Provide Quality Assurance leadership for complex validation projects and sound risk-based decision making.
• Review and approve validation documentation including plans, protocols, reports, risk assessments, change controls, and revalidation activities.
• Partner with R&D, Manufacturing, Engineering, and Quality teams to support new product introductions and readiness.
• Lead the site's Data Integrity Governance Program and ensure alignment with regulatory requirements.
• Establish governance for computerized systems including audits, access management, and remediation monitoring.
• Lead investigations and assess impact of significant validation or data integrity events on product quality and compliance.
• Monitor program performance through metrics and trend analysis, flag risks, and recommend improvements to site leadership.
• Support regulatory inspections and audits and drive continuous improvement through cross-functional mentoring.

Connaissances

Quality Assurance

Validation

Data integrity

Regulatory compliance

Cross-functional leadership

Formation

B.S. in Engineering

CQE/CSQE/CQA certification

Description du poste

Baxter International Inc. seeks a Senior Quality Assurance professional to lead site validation and data integrity programs, ensuring cGMP compliance and global regulatory expectations.

You’ll advise cross-functional teams and shape validation strategies to support product quality and patient safety across the site. The role involves governance, risk assessment, and collaboration with R&D, Manufacturing, and Quality teams to enable production readiness and continuous improvement.