Compliance Manager, Clinical Quality Assurance Oversight

Thermo Fisher Scientific

. Provide Clinical Quality oversight and support for clinical study teams .

Posted 10/13/2026full-timeRemote • North Carolina • United StatesSeniorLead💰 $95,000 - $140,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Clinical Quality Oversight and Compliance, with a strong understanding of Good Clinical Practices (GCP) and regulatory requirements. Proven ability to build relationships, facilitate Quality Risk Management, and promote a consistent Quality culture across clinical trial studies.

Highest-signal resume keywords

Clinical Quality OversightGood Clinical Practices (GCP)Clinical Trial RegulationsQuality Risk ManagementStakeholder Relationship Building

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Quality OversightQuality Risk ManagementCompliance ExperienceClinical Development ProcessesKey Quality Indicators AnalysisFDA RegulationsEU RegulationsICH GuidelinesQuality Metrics PresentationAudit and Inspection Activities

Soft Skills

Team MotivationEffective CommunicationRelationship BuildingProblem SolvingAdaptability

Tools & Technologies

Standard Office EquipmentQuality Management Systems

Industry Keywords

CROPharmaClinical TrialsQuality CulturePartnership Governance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide Clinical Quality oversight and support for clinical study teams
Serve as the dedicated, single point of Quality contact for the client
Partner with Operations to establish a consistent Quality culture across clinical trial studies or portfolios
Participate in regular partnership-level and ad hoc team meetings
Provide directions and recommendations for issue avoidance
Maintain continuous awareness and periodically review QE, SSM, SB, sPIP, audit, and inspection activities
Escalate appropriately to Client Quality, Quality Partner, Strategic Alliance Lead, bPL, PDL, or OD to minimize client impact and improve outcomes
Enable and facilitate Quality Risk Management
Prepare and analyze QA-related Key Quality Indicators for emerging trends and potential risks
Promote compliance with client-specific quality-event, audit, and inspection-response requirements
Incorporate quality insights into operational lessons learned and promote awareness across the portfolio
Drive Partnership Governance support
Co-chair Joint Quality Councils and contribute to other governance meetings
Present quality metrics and trends and discuss potential resolutions with relevant stakeholders

Requirements

What you’ll need

Bachelor’s degree or equivalent and relevant formal academic/vocational qualification
8+ years of previous compliance and quality experience, or comparable knowledge, skills, and abilities
Working knowledge of Good Clinical Practices (GCP)
CRO/Pharma industry experience required
In-depth knowledge of Clinical Trial-related FDA and EU regulations and ICH Guidelines
Strong knowledge of Clinical Development processes according to GCP and regulatory requirements
Proven experience building strong team and stakeholder relationships
Ability to motivate and educate clinical study teams on clinical quality aspects
Ability to translate quality culture and ways of working to study teams
Ability to communicate, receive, and understand information and ideas with diverse groups of people
Ability to work upright and stationary during typical working hours
Ability to use and learn standard office equipment and technology proficiently
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities
Estimated travel of 0–25%
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, including drug screening

Benefits

Comp & perks

Fully remote, home-based role
Variable annual bonus eligibility based on company, team, and/or individual performance
Relocation assistance is not provided