Thermo Fisher Scientific

Senior Compliance Specialist, FSP (Remote)

North Carolina, United States

Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Biotechnology, PharmaceuticalsIndustries

Requirements

Candidates must possess a Bachelor's degree or equivalent, with a minimum of 4+ years of clinical research experience in the pharmaceutical or biotechnology field. A Bachelor's degree is preferred. Essential qualifications include experience working within a GCP environment, solid knowledge of GCP compliance and regulatory inspection readiness, and a strong understanding of drug development and GCP compliance processes. The role also requires experience in problem-solving, negotiations, and collaborative team building, as well as solid knowledge of regulatory requirements governing clinical trials and industry best practices. Proficiency in Microsoft Office and the ability to resolve conflict constructively are necessary. Experience across all phases of the clinical study life cycle is preferred.

Responsibilities

The GCP Compliance Oversight Manager will lead process improvement initiatives, conduct risk assessments, and support mitigation planning. They will assist in updating procedural documents, provide recommendations for efficiency and compliance, and support cross-functional teams in implementing process changes. The role involves contributing to training programs, representing the department on projects, and interacting with internal and external personnel. Responsibilities include evaluating clinical trial processes for adherence to documentation, developing and maintaining KPIs and metrics, providing feedback on process and documentation quality, and representing GCP Compliance in meetings. The manager will also perform other assigned duties.

Skills

GCP Compliance
Clinical Trials
Process Improvement
Risk Assessment
Procedural Documents
Process Maps
Cross-functional Teams
Training Programs
KPIs
Metrics
Dashboards
Documentation Review

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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