Site Quality Lead: Strategic GMP & Compliance Champion

ThermoFisher Scientific; Guilford (CT); On-site; USD 103,000 - 150,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

401(k) plan

ESPP

Job summary

Thermo Fisher Scientific in Guilford, CT seeks a Site Quality Lead to oversee the Quality Management System and drive quality across the product lifecycle. You will balance strategic leadership with hands-on execution, ensuring compliance with regulatory requirements while enabling innovative solutions.

You will partner with Global Design Quality, Manufacturing, and Regulatory Affairs to ensure product quality, supplier performance, and manufacturing readiness across the site.

Qualifications

• 8+ years of quality experience in medical device/biotech/pharma environments.
• Experience supporting Design Controls and product development.
• Knowledge of ISO 13485, FDA QMSR, Design Controls, and Risk Management.

Responsibilities

• Own the site's Quality Management System, setting priorities and ensuring regulatory compliance.
• Lead Management Review activities and report on QMS health with meaningful metrics.
• Provide strategic quality leadership across the product lifecycle from development to post-launch.
• Identify systemic risks using data trends to drive improvements across products and processes.
• Collaborate with Global Design Quality, Manufacturing, Supplier Quality, Regulatory Affairs and operations.
• Oversee CAPA, deviations, change control, document control, training, and internal audits.

Skills

Cross-functional leadership

Quality system ownership

Regulatory compliance

Data-driven decision making

Quality metrics

Audit leadership

CAPA and deviations

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Thermo Fisher Scientific in Guilford, CT seeks a Site Quality Lead to oversee the Quality Management System and drive quality across the product lifecycle. You will balance strategic leadership with hands-on execution, ensuring compliance with regulatory requirements while enabling innovative solutions.

You will partner with Global Design Quality, Manufacturing, and Regulatory Affairs to ensure product quality, supplier performance, and manufacturing readiness across the site.