Remote Compliance Manager – Clinical Quality Assurance

Regulatory Jobs; North Carolina; Remote; USD 95,000 - 140,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Compliance Manager for the Clinical Quality Assurance group. This home-based role supports US east or central time zones, serving as the primary Quality contact for clinical study teams and driving a consistent quality culture across portfolios.

The role requires 8+ years in compliance, strong GCP knowledge, and CRO/pharma experience, with travel up to 25%. Relocation not provided, sponsorship not offered.

Qualifications

• 8+ years of compliance and quality experience.
• Working knowledge of GCP and FDA/ICH regulations.
• CRO/Pharma industry experience required.
• Equivalency of education and experience considered.

Responsibilities

• Provide Clinical Quality oversight for clinical study teams.
• Serve as single point of Quality contact for the client.
• Partner with Operations to foster a Quality culture across studies.
• Co-chair Joint Quality Councils and participate in governance meetings.
• Present quality metrics and trends and discuss resolutions with stakeholders.
• Escalate issues to minimize client impact and improve outcomes.

Skills

Team leadership

FDA regulations

ICH Guidelines

GCP knowledge

Regulatory compliance

Quality governance

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific is seeking a Compliance Manager for the Clinical Quality Assurance group. This home-based role supports US east or central time zones, serving as the primary Quality contact for clinical study teams and driving a consistent quality culture across portfolios.

The role requires 8+ years in compliance, strong GCP knowledge, and CRO/pharma experience, with travel up to 25%. Relocation not provided, sponsorship not offered.