Senior QA Lead - Validation & Data Integrity

Zvh; United States; On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Medical & Dental

ESPP (Employee Stock Purchase Plan)

401(k) Retirement Savings Plan

Paid time off 20-35 days

Disability & Life Insurance

Job summary

Baxter is seeking a Senior Quality Assurance professional to lead site validation and data integrity programs, ensuring cGMP compliance and global regulatory expectations. You will guide cross-functional teams to shape validation strategies and drive a culture of quality and accountability across the site.

The role emphasizes governance of computerized systems, regulatory inspections, and risk-based decision making, with a focus on patient safety and operational excellence.

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.
• Strong analytical, technical writing, investigation, and decision-making skills.
• Experience supporting regulatory inspections and audit activities.
• Ability to manage multiple priorities while maintaining a high level of quality and compliance.

Responsibilities

• Provide Quality Assurance leadership and oversight for complex validation projects, ensuring sound scientific and risk-based decision making throughout the system lifecycle.
• 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 commercial manufacturing readiness.
• Lead the site's Data Integrity Governance Program, ensuring alignment with GAMP 5, 21 CFR Part 11, ALCOA+ principles, and applicable regulatory requirements.
• Establish and maintain governance processes for computerized systems, including periodic reviews, audit trail requirements, user access management, and remediation effectiveness monitoring.
• Lead investigations and assess the impact of significant validation or data integrity events on product quality, compliance, and validated state.
• Monitor program performance through metrics and trend analysis, calling out risks and recommending improvements to site leadership.
• Support regulatory inspections and audits, present program strategy and evidence to inspectors, and drive continuous improvement through cross-functional collaboration and mentoring.

Skills

Quality Assurance

Validation

Data Integrity

Regulatory knowledge

Cross-functional leadership

Technical writing

Investigations

Education

Bachelor's degree in Engineering, Science, CS

Job description

Baxter is seeking a Senior Quality Assurance professional to lead site validation and data integrity programs, ensuring cGMP compliance and global regulatory expectations. You will guide cross-functional teams to shape validation strategies and drive a culture of quality and accountability across the site.

The role emphasizes governance of computerized systems, regulatory inspections, and risk-based decision making, with a focus on patient safety and operational excellence.