Sr Compliance Specialist

at  Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is seeking a highly motivated and experienced Clinical Compliance Specialist III to join our team. As a global leader in the industry, Thermo Fisher Scientific is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are a company that values inclusion and collaboration, where diverse experiences, backgrounds, and perspectives are highly valued.
In this role, you will have the unique opportunity to drive quality and compliance strategies across our organization. You will lead initiatives aimed at optimizing processes, behaviors, and performance, ensuring audit readiness. As a Clinical Compliance Specialist III, you will have the chance to interpret and analyze data, make sound business decisions, and successfully implement strategies with the support of a dedicated team.

Responsibilities:

• Use structured problem-solving methodology to address issues and document in accordance with ALCOA principles within specified timelines.
• Lead small to medium-scale process improvement initiatives.
• Connect with representatives from other departments regarding compliance activities such as client audits, CAPA, and procedural documents.
• Develop materials, presentations, and tools to support the department’s remit and strategies.
• Provide training and mentorship to junior team members.

Requirements:

• Bachelor’s degree or equivalent with a minimum of 5 years of relevant experience.
• Extensive knowledge of the clinical trial process and understanding of ICH GCP, as well as other relevant regulations and guidelines.
• Strong problem-solving skills, including root cause analysis and corrective/preventive actions.
• Excellent organizational and time-management skills.
• Attention to detail and strong digital literacy.
• Ability to prioritize competing demands and handle workload effectively.
• Flexibility, adaptability, and the ability to promote teamwork in a multi-disciplinary setting.
• Strong critical thinking skills and the ability to prioritize workload to deliver exceptional results.

Working Conditions and Environment:

• This is a remote home-based office position with infrequent domestic and international travel to office locations.
• The role may require working in an upright and/or stationary position for 6-8 hours per day.
• Light to moderate lifting and carrying of objects such as luggage and laptop computers may be required.
• Ability to perform under stress and maintain regular and consistent attendance.

Thermo Fisher Scientific Inc. is an Equal Opportunity Employer and offers accessibility services for job seekers requiring accommodations in the application process. If you are a job seeker with a disability, please contact us at 1-855-471-2255 to request assistance or accommodation.
Join our team today and contribute to our world-class organization dedicated to making a positive impact on global health and scientific advancement. #StartYourStory at Thermo Fisher Scientific.
Apply now:

• Use structured problem-solving methodology to address issues and document in accordance with ALCOA principles within specified timelines.
• Lead small to medium-scale process improvement initiatives.
• Connect with representatives from other departments regarding compliance activities such as client audits, CAPA, and procedural documents.
• Develop materials, presentations, and tools to support the department’s remit and strategies.
• Provide training and mentorship to junior team members