Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com

The Director, Compliance will report to the Head of Global Compliance. The incumbent will work to ensure the overall cGMP compliance profile is maintained specifically through the development and implementation of compliance processes and systems in a manner consistent with global quality systems requirements, corporate standards, current regulatory requirements and client requirements. Director will engage with key global regulators and identify mechanisms to assure that practices and policies meet current regulatory expectations.

Key Responsibilities:

Support the established Quality Compliance strategy. Work to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient way. Support in the development and executing inspection readiness programs and provide guidance on all compliance related matters.

Additional Responsibilities

• Support, implement, and lead an inspection readiness program. Provides on-site support for inspection management for key inspections. Responsible for efforts to respond to new or changing regulations, including but not limited to communicating regulations to leadership and affected areas assembling and chairing work teams.
• Develop education training regarding regulatory requirements and maturing a closed loop program for the effective implementation of major regulatory changes. To 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. Implements the required structures and operating mechanisms to maintain oversight of the compliance status of the business and achieve results.

Qualifications

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 is 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.

Up to 50% domestic and international travel.