Assoc III, Validation

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

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter

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. This is where you will apply your expertise to shape validation strategies, strengthen data integrity controls, and drive a culture of quality and accountability across the site. Success in this role is measured by the effectiveness of validation and governance programs, sustained compliance, inspection readiness, and the proactive management of quality and compliance risks.

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.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 - $132,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

• Medical and dental coverage that start on day one.
• Insurance coverage for basic life, accident, short‑term and long‑term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Time‑off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's