Quality Systems & Compliance Specialist III at Thermo Fisher Scientific

Swindon, England, 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, PharmaceuticalsIndustries

Requirements

Relevant science-based degree (e.g., Chemistry, Biology, Pharmacy or equivalent)
5 years relevant pharmaceutical/biotech experience in a regulated environment (e.g., FDA, EU GMP, JP)
Demonstrable understanding of the principles and guidelines for cGMP
Qualified Lead Auditor
Able to communicate well to all levels of the business
Up-to-date knowledge of standard processes, corporate, and regulatory requirements
Qualified trainer
Proficiency in electronic tools (e.g., Trackwise, eDMS, SFLMS)
Proactive approach to problem-solving and working to critical timelines
Embodiment of company values (integrity, intensity, innovation, involvement)
Strong motivation for improving and streamlining processes
Advocacy for EHS compliance

Responsibilities

Drive and sustain improvements to the Quality Management System (QMS) for compliance with cGMP regulations
Lead and support activities including risk management, internal & external audits, training, change control, deviations, CAPA, supplier assurance, document lifecycle, and metrics reporting
Act as process owner for one or more processes, ensuring ownership and accountability for process compliance
Lead internal audits to support site inspection readiness and collaborate sitewide to achieve key objectives
Share knowledge through structured training using innovative technologies
Write, review, and approve documents including procedures, deviations, CAPA, etc
Use electronic tools to support quality systems and compliance tasks
Extract, analyze, and interpret QMS data for management reporting, propose solutions to trends, and collaborate on resolutions
Provide inspiration, mentorship, and support to the team as a credible leader
Deputise for the Quality Compliance Manager to ensure continuity and effective management of compliance duties
Step up for other quality-related tasks as required
Participate actively in the continuous improvement program (PPI)
Ensure compliance with environment, health, and safety (EHS) rules and report accidents/near misses timely

Skills

cGMP

QMS

Risk Management

Internal Audits

External Audits

CAPA

Change Control

Supplier Assurance

Document Lifecycle

Trackwise

eDMS

SFLMS

Training

Metrics Reporting

Data Analysis

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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