Thermo Fisher Scientific

GCP Compliance Oversight Manager, FSP

North Carolina, United States

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates should possess a good understanding of clinical trial processes related to sponsor and CRO activities, including but not limited to sponsor oversight, issue management, site management, and clinical monitoring. A minimum of 4+ years of clinical research experience in the pharmaceutical or biotechnology field is required, along with solid knowledge of drug development, clinical trial management, and/or GCP compliance processes. Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs is necessary, as well as experience in problem solving, negotiations, and collaborative team building with non-direct reports and other stakeholders. A BS, MS, or equivalent in a scientific field is required, and the ability to efficiently utilize computer software programs such as Microsoft Office for general use, project management, and presentations is essential. Candidates must be able to resolve conflict constructively and possess a valid driver’s license with the ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.

Responsibilities

As a GCP Compliance Oversight Manager, the role involves planning, monitoring, and reporting on quality and compliance for selected clinical trial delivery processes, determining adherence and understanding of ICH GCP requirements. The position requires providing project-level QA support, collaborating with internal and external teams, conducting proactive and routine evaluations of clinical trial processes, promoting awareness of quality and regulatory compliance standards, participating in quality improvement activities, and developing and maintaining metrics, charts, and dashboards to track process quality and compliance. It also includes coordinating governance and compliance management processes, implementing quality awareness objectives, developing and maintaining quality and compliance mentorship/reference materials and tools, providing near real-time feedback on study process and documentation quality, ensuring compliance with personal learning requirements, and performing other duties as assigned.

Skills

Clinical trial processes
Sponsor oversight
Issue management
Site management
Clinical monitoring
GCP compliance
Quality assurance
Documentation review
Metrics and dashboard development
Regulatory standards awareness

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.

Key Metrics

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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