Compliance Manager – Clinical Quality Assurance Oversight

Thermo Fisher Scientific

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

Posted 10/26/2026full-timeRemote • United KingdomSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Quality Oversight and Risk Management, with a strong foundation in GCP and regulatory compliance. Proven ability to build relationships and facilitate quality culture across clinical study teams and partnerships.

Highest-signal resume keywords

Clinical Quality OversightGCP KnowledgePharmacovigilance ExperienceFDA and EU Regulations KnowledgeStakeholder Relationship Building

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Quality ManagementQuality Risk ManagementAudit and Inspection ActivitiesSafety-Reporting ProcessesKQI AnalysisRegulatory ComplianceClinical Development ProcessesQuality Event ManagementTrend AnalysisCorrective and Preventive Actions

Soft Skills

Relationship BuildingMotivational LeadershipEffective CommunicationTeam CollaborationProblem Solving

Industry Keywords

Clinical TrialsCROPharmaICH GuidelinesSafety-Data ReconciliationSerious Adverse Event ReportingQuality CulturePartnership GovernanceJoint Quality CouncilsCompliance Risks

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide Clinical Quality oversight and support to 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 studies or portfolios
Participate in regular partnership-level and ad hoc team meetings
Provide directions and recommendations for issue avoidance
Maintain continuous awareness and conduct periodic reviews of 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 KQIs for emerging trends and potential risks
Partner with Clinical Operations and PV to identify, assess, and mitigate risks to participant safety and reporting compliance
Review trends in SAE reporting timeliness, safety-data reconciliation, and PV vendor performance, and support follow-up actions
Promote compliance with client-specific requirements related to quality events, audits, and inspection responses
Incorporate quality insights into operational lessons learned and promote awareness across the portfolio
Drive support for Partnership Governance
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 is required
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
8+ years of comparable experience, or equivalent combination of education, training, and experience
Working knowledge of GCP is required
Proven experience building strong relations is required
Experience working with CRO and/or Pharma companies is required
Preferably experience partnering with PV or Drug Safety teams in clinical development, including support for safety-reporting processes and follow-up of PV-related quality events, audit findings, or corrective and preventive actions
In-depth knowledge of Clinical Trial-related FDA and EU regulations and ICH Guidelines
Current and strong knowledge of Clinical Development processes according to GCP and regulatory requirements
Preferably working knowledge of pharmacovigilance requirements relevant to clinical trials, including ICH E2A and applicable FDA and EU safety-reporting requirements
Ideally, ability to recognize and escalate PV quality and compliance risks involving serious adverse event reporting, safety-data reconciliation, reporting timelines, and PV vendor or partner oversight
Ability to motivate and educate clinical study teams on clinical quality aspects
Capability to build effective relationships with internal and external stakeholders
Ability to translate quality culture and ways of working to study teams
Fully remote, ideally Central time zones
Relocation assistance is NOT provided

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule
0–25% travel may be required
Relocation assistance is NOT provided