Assoc III, Validation
Baxter International Inc.
Summary
As a Senior Quality Assurance professional, you will provide strategic leadership for site validation and data integrity programs, ensuring compliance with cGMP requirements and global regulatory expectations. You will serve as a trusted advisor to cross-functional teams, influencing critical quality decisions that support product quality, patient safety, and operational excellence.
Job description
What you'll be doing
- 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.
What you'll bring
- 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.
- Must meet all applicable site safety and occupational requirements.
- 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 Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), or equivalent certification.
Requirements
- 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.
- Must meet all applicable site safety and occupational requirements.
- 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 Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), or equivalent certification.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Accident Insurance
- Short-term Disability
- Long-term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family and Medical Leave
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.