Quality Validation & Data Integrity Leader

Zvh; United States; On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Health insurance & dental

401(k) with company match (ESPP)

Paid holidays & PTO (20–35 days)

Educational assistance

Parental leave

Job summary

Baxter is seeking a Quality Engineering Manager to lead the validation and data integrity governance at the site. You will partner with Engineering, Facilities, Operations, CSV, laboratories, and system owners to drive program execution and ensure compliance with regulatory requirements.

As the primary QA representative for validation, you will interface with site leadership and regulatory agencies, drive remediation activities, and maintain independent QA oversight through governance, review,

Qualifications

• Expert knowledge of cGMP validation, GAMP 5, and 21 CFR Part 11.
• Proven people leadership and ability to build high-performing teams.
• Ability to organize plans, governance, and risk-based decisions.
• Maintain QA independence while partnering with Engineering, Facilities, Operations, CSV, laboratories, and leadership.
• Excellent written and oral communication, including regulatory presentations.
• Proven success leading complex programs, inspections, and remediation governance.
• Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems.
• Meet all site safety and occupational requirements.

Responsibilities

• Establish site strategy, governance model, procedures, and QA oversight of validation and data integrity.
• Lead and performance-manage the Quality Engineering team; assign oversight by risk and priority.
• Ensure ownership across Engineering, Facilities, Operations, CSV, laboratories, and system owners for validation activities.
• Approve or delegate master plans, high-risk protocols, reports, deviations, and remediation decisions.
• Chair or sponsor governance forums; set risk-based priorities and resolve cross-functional conflicts.
• Align data integrity program with GAMP 5, 21 CFR Part 11, ALCOA+ and regulatory expectations.
• Review program health through metrics, audits, aging, and trend analysis; raise risks to leadership.
• Ensure remediation plans have milestones, controls, and QA verification of closure.
• Represent validation and data integrity during FDA inspections, audits, and regulatory submissions.
• Develop capability, succession plans, training, and standardized tools for QA and partners.
• Manage resources to maintain compliant, efficient QA oversight.

Skills

cGMP validation

Quality systems

Regulatory compliance

Leadership

Data integrity governance

QA independence

Regulatory presentations

Education

Bachelor's degree in Engineering/Science

ASQ CQE/CSQE/CQA or Six Sigma

Tools

Electronic quality systems

Job description

Baxter is seeking a Quality Engineering Manager to lead the validation and data integrity governance at the site. You will partner with Engineering, Facilities, Operations, CSV, laboratories, and system owners to drive program execution and ensure compliance with regulatory requirements.

As the primary QA representative for validation, you will interface with site leadership and regulatory agencies, drive remediation activities, and maintain independent QA oversight through governance, review,