Director, Compliance

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Life SciencesIndustries

Requirements

Candidates must possess a degree in Chemistry, Biotech, or Pharmacy, or an equivalent field, with over 12 years of cGMP experience in the global pharmaceutical industry. Experience with regulatory authorities from an auditing perspective in a pharmaceutical GMP environment is essential, along with knowledge and experience in quality assurance functions. Preferred qualifications include experience with remediation, interpersonal build, or transformational work, and the capability to network within the pharmaceutical industry and partner strategically with international regulators. The role requires the ability to collaborate and communicate effectively under pressure, and involves 25% domestic and international travel.

Responsibilities

The Director, Compliance will support the established Quality Compliance strategy and work towards continuous improvements in national and international cGMP compliance standards. They will support the development and execution of inspection readiness programs, provide guidance on compliance-related matters, and offer on-site support for key inspections. Responsibilities include responding to new or changing regulations, communicating these to leadership, and assembling work teams. The role also involves developing educational training on regulatory requirements, proactively interpreting and establishing quality systems to ensure compliance with all applicable regulations, identifying and communicating key regulatory updates, and delivering safe and effective products. The Director will implement structures and operating mechanisms to maintain oversight of the business's compliance status and achieve results, aiming for outstanding GMP regulatory compliance with zero patient impacting events.

Skills

cGMP compliance

Quality Systems

Regulatory Requirements

Inspection Readiness

Compliance Strategy

Global Regulations

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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