Assoc III, Validation (Data Integrity)

Location: Round Lake, Illinois, United States

Salary: $96,000–$132,000 annually

Company

Healthcare company focused on developing and delivering products and solutions that support patient safety and improve healthcare delivery.

What you will do

• Provide Quality Assurance leadership for complex validation projects using scientific and risk-based decision-making throughout the system lifecycle.
• Review and approve validation plans, protocols, reports, risk assessments, change controls, and revalidation activities.
• Partner with R&D, Manufacturing, Engineering, and Quality teams on new product introductions and commercial manufacturing readiness.
• Lead the site Data Integrity Governance Program, including computerized system reviews, audit trails, user access management, and remediation monitoring.
• Lead investigations into validation and data integrity events and assess impacts on product quality, compliance, and the validated state.
• Monitor program metrics, support regulatory inspections and audits, and drive continuous improvement through cross-functional collaboration and mentoring.

Requirements

• Bachelor’s degree in Engineering, Science, Computer Science, or a related technical field.
• At least 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, data integrity, risk management, GAMP 5, 21 CFR Part 11, ALCOA+ principles, and applicable regulatory requirements.
• Experience reviewing validation documentation, assessing compliance risks, leading cross-functional initiatives, and supporting regulatory inspections and audits.
• Strong analytical, technical writing, investigation, communication, and decision-making skills, with the ability to manage multiple priorities.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Experience leading site-wide data integrity or computerized system governance programs.
• Direct interaction with regulatory agencies during inspections involving validation, computerized systems, or data integrity.
• ASQ CQE, CSQE, CQA, or equivalent certification.

Culture & Benefits

• Mission-driven environment focused on saving and sustaining lives.
• Culture of courage, trust, collaboration, ownership, and accountability.
• Medical and dental coverage beginning on day one, plus life, accident, disability, and business travel insurance.
• 401(k) retirement plan with company matching, employee stock purchase plan, flexible spending accounts, and educational assistance.
• Paid holidays, 20–35 days of paid time off depending on tenure, family and medical leave, paid parental leave, commuting benefits, and childcare benefits.