Compliance Manager, Clinical Quality Assurance Oversight

Thermo Fisher Scientific seeks a Compliance Manager for its Clinical Quality Assurance group to oversee clinical study quality, manage regulatory compliance, and serve as the primary quality contact for clients. The remote role is based in the US East or Central time zone and requires extensive clinical research and regulatory expertise.

Responsibilities

• Provide clinical quality oversight and serve as dedicated quality contact for clients
• Partner with operations to establish consistent quality culture across trial portfolio
• Monitor and review quality events, audits, inspections, and related metrics for emerging risks
• Co-chair Joint Quality Councils and present quality metrics and trends to stakeholders
• Prepare recommendations to prevent issues and escalate concerns to appropriate leadership

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 8+ years compliance and quality experience in CRO or pharma industry
• Working knowledge of Good Clinical Practices (GCP) and FDA/EU regulations
• In-depth knowledge of ICH Guidelines and clinical development processes
• Proven ability to build strong relationships with teams and stakeholders
• Ability to communicate complex quality concepts to diverse study teams
• Legal authorization to work in the United States without sponsorship

Compensation: $95,000-$140,000 USD annual salary, plus variable annual bonus