Quality Engineering Lead - Validation & Data Integrity

Baxter Healthcare; Town of Round Lake (WI); On-site; USD 112,000 - 154,000; Full time

Job summary

Baxter Healthcare in Round Lake, IL is seeking a Quality Engineering Manager to oversee the site validation program and data integrity governance. You will set strategy, standards, and risk tolerance, partnering with Engineering, Facilities, Operations, CSV, and laboratories to ensure compliance and effective program execution.

As the primary Quality representative for validation and data integrity, you will lead a team, approve master plans and change controls, and chair governance forums,

Qualifications

• Expert knowledge of cGMP validation, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance
• Demonstrated people leadership and ability to build high-performing technical teams
• Proven capability in organizing plans, governance, and risk-based decision making

Responsibilities

• Establish site strategy and governance for QA oversight of validation and data integrity.
• Lead, develop, and performance-manage the Quality Engineering team; assign oversight by risk and priority.
• Ensure accountability for validation authoring, execution, and remediation; maintain QA independence.

Skills

Quality leadership

Regulatory compliance

Risk management

Effective communication

Independent QA oversight

Education

Bachelor’s degree in Engineering/Science/CS

ASQ CQE/CSQE/CQA certification desirable

Job description

Baxter Healthcare in Round Lake, IL is seeking a Quality Engineering Manager to oversee the site validation program and data integrity governance. You will set strategy, standards, and risk tolerance, partnering with Engineering, Facilities, Operations, CSV, and laboratories to ensure compliance and effective program execution.

As the primary Quality representative for validation and data integrity, you will lead a team, approve master plans and change controls, and chair governance forums,