Strategic QA Leader — Global Central Laboratories

ThermoFisher Scientific; Highland Heights (KY); On-site; USD 140,000 - 210,000; Full time

Job summary

Thermo Fisher Scientific seeks an Associate Director, Quality Assurance for the Global Central Laboratories in the Highland Heights, KY region. This leader will oversee QA systems supporting clinical laboratory services, biorepository, and related operations, ensuring compliance with regulatory and client requirements while promoting a culture of quality and inspection readiness.

The role partners with laboratory operations and senior leadership to drive continuous improvement, risk management,

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 10+ years of QA experience in regulated labs/healthcare environments.
• 5+ years in leadership/management of QA teams.
• Experience with lab quality systems, regulatory compliance, audits.

Responsibilities

• Lead QA team across laboratory quality operations.
• Oversee quality management systems including deviations, investigations, CAPA, change control, document control, audits, training, risk management, and quality metrics.
• Ensure regulatory compliance with CLIA, CAP, ISO 15189, NYS, FDA, EMA, GMP/GLP.
• Lead internal, client, regulatory audits and inspections; drive inspection readiness.
• Drive continuous improvement; partner cross-functionally to identify quality risks and mitigate issues.

Skills

QA leadership

Regulatory compliance

CAPA investigations

Audit management

Data integrity

Risk management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

Quality management systems

Job description

Thermo Fisher Scientific seeks an Associate Director, Quality Assurance for the Global Central Laboratories in the Highland Heights, KY region. This leader will oversee QA systems supporting clinical laboratory services, biorepository, and related operations, ensuring compliance with regulatory and client requirements while promoting a culture of quality and inspection readiness.

The role partners with laboratory operations and senior leadership to drive continuous improvement, risk management,