QA Validation Leader — cGMP & Compliance

ThermoFisher Scientific; Teterboro (NJ); On-site; USD 113,000 - 169,000; Full time

Benefits offered by this job

Total Rewards package

Stock Purchase Plan (ESPP)

Health, dental and vision plans

PTO and holidays

Job summary

Thermo Fisher Scientific’s Ridgefield, NJ sterile fill-finish site is seeking a Quality Assurance Validation Manager to lead validation programs across equipment, utilities, facilities and systems. You will ensure compliance with cGMP, guide risk-based decisions, and drive continuous improvement in validation practices.

In this role you will partner with QA, Manufacturing, Engineering and Regulatory Affairs to maintain validated states, manage change control, and mentor a team of validation

Qualifications

• Significant validation experience in pharma/biotech or regulated environments.
• Experience coordinating, planning, executing, and approving validation activities across disciplines.
• Proven success managing complex validation projects, programs, and teams.
• Experience with regulatory inspections and customer audits.
• Knowledge of data integrity, ALCOA+ and regulatory expectations.
• Proficiency with validation master planning and change control systems.

Responsibilities

• Lead and manage validation activities across manufacturing, laboratory, utility, facility, computerized systems, and analytical instruments.
• Develop and maintain validation strategies, validation master plans, and project timelines.
• Oversee the planning, coordination, execution, review, and approval of validation protocols and reports.
• Partner with project managers and cross-functional stakeholders to establish priorities and communicate status.
• Ensure validation activities comply with FDA, EU, and global regulatory requirements.
• Support qualification programs for equipment, processes, cleaning, utilities, computer systems, and analytical instruments.
• Apply risk assessment methodologies and statistical tools to support validation decisions.
• Drive continuous improvement initiatives to enhance validation processes and efficiency.
• Manage change control activities and assess validation impacts of changes.
• Ensure data integrity governance across validation activities.
• Support regulatory inspections and audits.
• Mentor and develop validation professionals.

Skills

cGMP regulations

Equipment qualification

Process validation

Analytical instrument qualification

Computer system validation

Change control

Data integrity

Risk assessment

Regulatory inspections

Leadership

Cross-functional collaboration

Education

Advanced Degree

Bachelor's Degree

Life Sciences fields (Engineering/Chemistry/Biology)

Tools

Equipment qualification

Process validation

Cleaning validation

Computer system validation

Utility qualification

Analytical instrument qualification

Job description

Thermo Fisher Scientific’s Ridgefield, NJ sterile fill-finish site is seeking a Quality Assurance Validation Manager to lead validation programs across equipment, utilities, facilities and systems. You will ensure compliance with cGMP, guide risk-based decisions, and drive continuous improvement in validation practices.

In this role you will partner with QA, Manufacturing, Engineering and Regulatory Affairs to maintain validated states, manage change control, and mentor a team of validation