Director, Compliance at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, BiotechnologyIndustries

Requirements

Degree in Chemistry, Biotech, Pharmacy or equivalent
12+ years of cGMP experience in a global pharmaceutical industry
Experience with regulatory authorities from an auditing perspective in a pharmaceutical GMP environment
Experience with remediation, interpersonal build or transformational work (highly preferred)
Knowledge and experience with quality assurance functions
Capability to network within the pharmaceutical industry and partner strategically with international regulators
Capability to collaborate and effectively communicate under pressure
25% domestic and international travel

Responsibilities

Support the established Quality Compliance strategy and ensure continuous improvements regarding the most recent national and international cGMP compliance standards
Support the development and execution of inspection readiness programs and provide guidance on all compliance related matters
Support, implement, and lead an inspection readiness program
Provide on-site support for inspection management for key inspections
Respond to new or changing regulations, including communicating regulations to leadership and affected areas, and assembling and chairing work teams
Develop education training regarding regulatory requirements and mature a closed loop program for the effective implementation of major regulatory changes
Ensure compliance of all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems
Identify and communicate key regulatory updates pertinent to the business
Deliver safe & effective products and make Quality a competitive advantage by achieving outstanding GMP regulatory compliance with zero patient impacting events and drive quality strategy and culture
Implement the required structures and operating mechanisms to maintain oversight of the compliance status of the business and achieve results

Skills

Key technologies and capabilities for this role

cGMPComplianceQuality SystemsInspection ReadinessRegulatory AffairsInspection ManagementGlobal Compliance

Questions & Answers

Common questions about this position

What qualifications are required for the Director, Compliance position?

A degree in Chemistry, Biotech, Pharmacy or equivalent is required, along with 12+ years of experience.

Is this a remote position or does it require office work?

The position is office-based with a standard Monday-Friday work schedule.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the company culture emphasize at Thermo Fisher Scientific?

The company focuses on enabling customers to make the world healthier, cleaner, and safer, delivering innovative technologies and driving quality strategy and culture with outstanding GMP regulatory compliance.

Who does the Director, Compliance report to?

The Director, Compliance reports to the Head of Global Compliance.

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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