Thermo Fisher Scientific · 8 hours ago
Quality Oversight Lead-- fully remote!
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expThermo Fisher Scientific is a global leader in serving science, dedicated to impactful work and innovative thinking. The Quality Oversight Lead will provide Clinical Quality oversight and support to clinical study teams, ensuring compliance with GCP and local regulatory requirements throughout the clinical development process.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
To provide Clinical Quality oversight and support to the clinical study teams
To pro-actively implement quality principles during the clinical design and set-up, study conduct, and reporting, providing continuous support and input during the Clinical Development Activities in the GCP area
Provides Quality principles and quality insights to the study team at study design and start up
Acts as the first point of contact for any quality related questions/ concerns for study teams
Owns the Quality role on study level by providing continuous quality compliance support and by acting as an internal advisor to the study team on relevant processes, procedural documents, and regulations to ensure correct interpretation and implementation
Ensures alignment with client quality and the quality agreement, and is the conduit to consult with the client on study quality issues and investigational strategies to ensure transparency of direction
Leads the quality oversight for assigned clinical studies in close collaboration with the study team
Provides guidance to the clinical study team to ensure clinical studies are executed and compliant to GCP and local regulatory requirements
Supports the design of study risk management plans and the definition of appropriate risk responses + QTLs; helps to mitigate quality compliance risks
Coordinates and supports in GCP audits as needed with the appropriate partnership role to ensure audit focus and scopes are determined correctly at study level and to ensure GCP compliance throughout the study and audits are assigned on a risk-based level
In close collaboration with client quality staff escalates quality / compliance / privacy issues and supports investigation and definition of necessary corrective and preventive measures
In close collaboration with client quality staff and per procedure contributes to the assessment, evaluation, and investigation of any (potential) serious breaches
Leads, in collaboration with study teams, inspection readiness activities and participates in inspections as defined by the client, in collaboration with internal study teams
Qualification
Required
Bachelor's degree is required
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years') or equivalent combination of education, training, & experience
Working knowledge of GCP is required
Proven Experience In Building Strong Relations Is Required
Experience working with CRO and/or Pharma companies is required
Ability to co-exist in 2 organizations and navigate organizational structures and dotted line reporting line(s) to achieve clear communication and transparency
In‐depth knowledge of all Clinical Trial related FDA and EU regulations and ICH Guidelines
Current and strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP) and regulatory requirements
Ability to motivate and educate the clinical study team on clinical quality aspects
Capable of building effective relationships with internal and external stakeholders
Ability to translate quality culture and ways of working to study teams
0-25% travel may be required
Must be legally authorized to work in the US without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
CB Insights
2026-01-23
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