[Remote] Principal Operational Process and Compliance Specialist at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years)
Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job
Broad understanding of procedural documents
Excellent understanding of process improvement practices
Advanced investigative and analytical skills
Strong negotiation skills
Broad understanding of clinical management technology and systems, and strong computer skills
Familiarity with the practices, processes, and requirements of clinical trials
Strong judgment, decision making, escalation, and risk management skills
Effective oral and written communication skills including the ability to communicate in English, both orally and in writing

Responsibilities

Leads mid-to-large scale, complex process improvement initiatives across departments
Proactively conducts in-depth risk assessments and develops mitigation strategies for quality concerns
Establishes and maintains process governance frameworks to ensure consistency in quality and compliance practices
Analyzes trends and provides insights for process optimization and compliance improvement
Collaborates with senior leadership to align process improvements with business priorities
Mentors less experienced team members providing guidance on best practices in quality and process management
May act as a subject matter expert in an assigned area
Creates formal networks with key contacts outside own area of expertise
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead)

Skills

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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