Senior QA: Validation & Data Integrity Lead

Baxter International Inc.

Round Lake (IL)

On-site

USD 96,000 - 132,000

Full time

41 hours ago

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Benefits offered by this job

Health benefits

Performance bonuses (discretionary)

Comprehensive wellness programs

Job summary

Baxter International Inc. is seeking a Senior Quality Assurance professional to provide strategic leadership for site validation and data integrity programs, ensuring cGMP compliance and global regulatory expectations.

You will influence cross-functional teams to shape validation strategies, strengthen data integrity, and drive a culture of quality and accountability across the site. This role partners with R&D, Manufacturing, and Quality to support new product introductions and commercial

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 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 quality and compliance.
Must meet all site safety and occupational requirements.
Experience leading 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.

Responsibilities

Provide QA leadership for complex validation projects and risk-based decisions.
Review and approve validation plans, protocols, reports, and change controls.
Partner with R&D, Manufacturing, Engineering, and Quality for new product introductions and readiness.
Lead Data Integrity Governance to align with GAMP 5 and 21 CFR Part 11.
Govern computerized systems with periodic reviews, audit trails, and access controls.
Lead investigations and assess impact of validation or data integrity events.
Monitor program performance with metrics and trend analysis.
Support regulatory inspections and drive cross-functional improvements.