[Remote] Clinical Compliance Manager at Thermo Fisher Scientific

United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Life Sciences, HealthcareIndustries

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), or equivalency consisting of a combination of appropriate education, training, and/or directly related experience
Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
Strong organizational and time-management skills
Extensive knowledge of the clinical trial process
Comprehensive knowledge and understanding of ICH GCP and other relevant regulations and guidelines
Highly developed problem-solving skills, including root cause analysis, corrective/preventive action(s), and effectiveness checks
Ability to work independently or in a team environment
Strong negotiation and conflict management skills
Strong attention to detail
Strong computer skills; ability to learn and become proficient with appropriate software
Demonstrated ability to prioritize competing demands and manage workload
Proven flexibility and adaptability
Effective judgment, decision making, escalation, and risk management skills
Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
Strong creative and critical thinking skills

Responsibilities

Research and address issues using problem-solving methodology, documents in accordance with ALCOA principles, and tracks metrics related to quality and compliance activities
Lead quality and compliance processes and ensure appropriate execution and completion
Lead and/or participate in process improvement initiatives
Communicate with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA, and/or procedural documents)
Develop varied support materials, presentations, and/or tools to support department's remit and strategies
Provide training and guidance to junior team members
Execute quality and compliance strategies and initiatives across the organization
Manage assigned initiatives aimed at supporting quality delivery and compliance to optimize processes, behaviors, performance, and audit readiness
Interpret data on complex issues, lead teams, and make good business decisions with support
Provide mentoring and expertise to advance the vision of the department

Skills

Quality Management

Compliance

Problem Solving

ALCOA Principles

CAPA

Process Improvement

Audit Readiness

Data Analysis

Training

Team Leadership

Metrics Tracking

Presentations

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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