Quality Oversight Lead-- fully remote! at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Life SciencesIndustries

Requirements

Bachelor's degree (or equivalency of appropriate education, training, and/or directly related experience)
Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent combination of education, training, & experience
Working knowledge of GCP
Proven experience in building strong relations
Experience working with CRO and/or Pharma companies
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

Responsibilities

Provide Clinical Quality oversight and support to the clinical study teams
Pro-actively implement quality principles during clinical design and set-up, study conduct, and reporting, providing continuous support and input during Clinical Development Activities in the GCP area
Provide Quality principles and quality insights to the study team at study design and start up
Act as the first point of contact for any quality related questions/concerns for study teams
Own the Quality role on study level by providing continuous quality compliance support and acting as an internal advisor to the study team on relevant processes, procedural documents, and regulations to ensure correct interpretation and implementation
Ensure alignment with client quality and the quality agreement, and act as the conduit to consult with the client on study quality issues and investigational strategies to ensure transparency of direction
Lead the quality oversight for assigned clinical studies in close collaboration with the study team
Provide guidance to the clinical study team to ensure clinical studies are executed and compliant to GCP and local regulatory requirements
Support the design of study risk management plans and the definition of appropriate risk responses + QTLs; help to mitigate quality compliance risks
Coordinate and support 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, escalate quality/compliance/privacy issues and support investigation and definition of necessary corrective and preventive measures
In close collaboration with client quality staff and per procedure, contribute to the assessment, evaluation, and investigation of any (potential) serious breaches
Lead, in collaboration with study teams, inspection readiness activities and participate in inspections as defined by the client, in collaboration with internal study teams

Skills

Key technologies and capabilities for this role

GCPClinical Quality OversightQuality AssuranceRegulatory ComplianceStudy DesignRisk ManagementQuality AgreementsClinical DevelopmentProcedural Documents

Questions & Answers

Common questions about this position

Is this position fully remote?

Yes, this is a fully remote position.

What is the salary range for this role?

This information is not specified in the job description.

What are the key responsibilities of this role?

The role involves providing Clinical Quality oversight to study teams, implementing quality principles during clinical design, conduct, and reporting, acting as the first point of contact for quality questions, leading quality oversight for assigned studies, and supporting GCP audits and inspections.

What is the company culture like at Thermo Fisher Scientific?

The company features a culture dedicated to impactful work, innovative thinking, working the right way with the customer top of mind, and empowering colleagues to realize their full potential in a fast-growing global organization that values passion and unique contributions.

What experience makes a strong candidate for this position?

Strong candidates will have expertise in clinical quality oversight, GCP compliance, quality principles in clinical development, risk management, and experience supporting audits and inspections in a clinical study environment.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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