Easter Seals Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 will ensure that the overall cGMP compliance profile is maintained for the organization and sites; 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. Engage effectively with key global regulators, i.e, FDA, EMA, ANVISA and identify mechanisms to assure that our practices and policies meet current regulatory expectations.

Key Responsibilities:

We are seeking an ideal candidate who can establish a Global Quality Compliance strategy and direction throughout the Compliance organization. Work to ensure continuous improvements regarding the most recent national and international cGMP compliance standards. The position will, 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:

Attract and retains top talent to build an outstanding Compliance function. Implements the required interpersonal structures and operating mechanisms to maintain appropriate oversight of the compliance status of the business and achieve results. Develop, implement and lead an inspection readiness program. Develop and maintain quality assurance and compliance polices and standard operating procedures, meeting domestic and global regulations and corporate policies.

Provides on-site support for inspection management for key inspections. Ensure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems. Deliver safe & effective products and make Quality a competitive advantage by achieving an outstanding GMP regulatory compliance with zero patient impacting events and drive quality strategy and culture. Deliver new compliance programs and structures to assure compliance with new and emerging regulations.

Qualifications:

• Degree in Chemistry, Biotech or Pharmacy or equivalent. 15+ years of cGMP experience in the pharmaceutical industry in a global environment. Experience leading regulatory inspections are considered required for the role.

• Experience with management of medical device combination products. Experience with regulatory authorities from an auditing perspective with regulatory experience in a pharmaceutical GMP environment highly preferred. Experience with remediation.

• Capability to network within the pharmaceutical industry and partner with international regulators.

• Travel 25%

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.