Director, DPD North America GMP and Regulatory Compliance

at  Thermo Fisher Scientific

JOB DESCRIPTION

We are currently seeking a highly motivated and experienced individual to join our team as the Director, DPD North America GMP and Regulatory Compliance at Thermo Fisher Scientific Inc. This is a remarkable opportunity to join a top-notch manufacturing team and contribute to the development of advanced scientific solutions that have a positive impact on global health, environment, and safety.
The Director, DPD-NA GMP and Regulatory Compliance provides oversight, guidance and support to the NA Region sites ensuring consistent adherence to cGMP requirements and Quality standards as promulgated by NA and various international regulatory bodies of competent jurisdiction, Thermo Fisher Scientific corporate standards and standard operating procedures, and customer expectations.
Responsibilities:
Lead and develop a team of manufacturing professionals to ensure flawless execution of Good Manufacturing Practices (GMP) and regulatory compliance across North America.
Develop and implement strategies to continuously improve manufacturing processes, ensuring the highest quality standards are met.
Collaborate with cross-functional teams to identify and implement effective strategies, streamline operations, and drive operational excellence.
Lead the creation and execution of training programs to ensure that all employees possess the crucial knowledge and skills required to meet GMP and regulatory standards.
Proactively identify and mitigate potential risks and compliance issues, ensuring strict adherence to all relevant regulations and standards.
Requirements:
Bachelor’s degree in a scientific or engineering field, with 15 years+ of pharmaceutical industry experience in similar role. Experience in injectable sterile manufacturing and in biotech and vaccine production preferable.
Demonstrated understanding of quality structures and regulatory bodies (national and international)
Extensive experience in GMP and Pharmaceutical Regulatory Compliance.
Able to mentor and lead cross-functional teams, also in crisis situations and through long term cultural change and business development.
Understanding of pharma supply chain
Understanding of site and product auditing.
Solid understanding of GMP regulations, quality systems, and regulatory requirements within the pharmaceutical or biotech industry.
Excellent leadership skills, effectively manage and motivate a diverse team.
Exceptional problem-solving and decision-making abilities, with a focus on driving continuous improvement.
Excellent communication and interpersonal skills, with the ability to collaborate optimally with stakeholders at all levels.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. We believe that diversity drives innovation and we welcome applicants from all backgrounds and experiences. Reasonable accommodations will be provided to applicants with disabilities throughout the application process. If you require accommodations or have any accessibility needs, please contact us at 1-855-471-2255 or include specific details in your application.

Please refer the Job description for details