JOB DESCRIPTION

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.

POSITION SUMMARY

The Sr. 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. Sr Director will engage with key global regulators to include FDA, EMA, and ANVISA; and identify mechanisms to assure that our practices and policies meet current regulatory expectations.

REQUIREMENTS

Degree in Chemistry, Biotech, Pharmacy or equivalent. 15+ years of cGMP experience in a global pharmaceutical industry. Experience with regulatory authorities from an auditing perspective with regulatory experience in a pharmaceutical GMP environment highly preferred. Experience with remediation, e.g. warning letters and consent decrees and interpersonal build or transformational work is highly preferred. Experience with management of medical device combination products.
Knowledge, experience, and skills with quality assurance functions; and the use of information technology platforms. Capability to network within the pharmaceutical industry and partner strategically with international regulators. Capability to collaborate effectively across global quality network. Effective communication under pressure. 25% domestic and international travel.

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. Develop and lead inspection readiness programs and provide guidance on all compliance related matters. Advise on industry issues and regulatory changes that may affect PSG.

ADDITIONAL RESPONSIBILITIES:

• Support development, implement, and lead an inspection readiness program. Provides on-site support for inspection management for key inspections. Develop and maintain quality assurance and compliance polices and standard operating procedures, meeting domestic and global regulations and corporate policies.
• 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. Developing education regarding regulatory requirements and maturing a closed loop program for the effective implementation of major regulatory changes. To ensure compliance to 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 interpersonal structures and operating mechanisms to maintain appropriate oversight of the compliance status of the business and achieve results.