JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of over 120,000 colleagues offers an outstanding mix of brand new technologies, convenient purchasing options, and pharmaceutical services across our top brands like Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• Master’s degree in biology, Immunology, or a related scientific field, preferably with additional qualifications or certifications relevant to the IVD industry.
• Profound experience in assay or medical device development, with a proven track record in managing product life cycles and compliance in a highly regulated environment.
• Strong leadership and problem-solving skills, excellent organizational abilities, and proficiency in managing complex projects and initiatives.
• Exceptional communication skills with fluency in English, both written and spoken, necessary for effective collaboration across diverse teams and collaborators. German is a plus.

• CAPA Management: Lead the strategic oversight and execution of Corrective and Preventive Actions (CAPA) to resolve product-related issues, ensuring timely and compliant closure of CAPAs.
• Regulatory Compliance: Ensure all product care activities adhere to regulatory guidelines, including IVDR and ISO13485, maintaining up-to-date product documentation and compliance records.
• Cross-Functional Collaboration: nurture strong relationships with R&D, Production Planning, Marketing, QA/RA, and other departments to effectively run CAPA and NC processes, ensuring seamless operational flow and adherence to regulatory standards.
• Continuous Improvement: Champion continuous improvement initiatives to enhance product quality and performance, applying root cause analysis to prevent recurrence of issues.
• Audit and Documentation Management: Prepare for and lead defense in internal and external audits; manage and be responsible for the creation and maintenance of all product care documentation to ensure full regulatory compliance.
• Team Leadership: Manage and develop a scientific team dedicated to product care activities, promoting professional growth and ensuring efficient and effective task completion.