Sr Compliance Specialist

Thermo Fisher Scientific • Morrisville, NC

1d • Onsite

About The Position

The Senior Compliance Specialist executes quality and compliance strategies and initiatives across the organization and manages the tracking and reporting of quality and compliance activities. The role involves maintaining tools and materials, serving as project lead and providing mentoring and expertise to advance the vision of the department. What You'll Do:
Research and addresses issues, track metrics and maintain reports and documentation related to quality and compliance activities.
Lead quality and compliance processes and ensure appropriate execution and completion.
Lead smaller projects and/or some process/quality improvement initiatives.
Communicate with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).
Mentor staff and serve as a team lead for group projects or process improvement initiatives.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Excellent oral and written communication skills
• Strong organizational and time-management skills
• Extensive knowledge of the clinical trial process
• Comprehensive knowledge and understanding of ICH GCP and other relevant regulations and guidelines
• Demonstrated problem solving skills
• Excellent attention to detail
• Strong computer skills; ability to learn and become proficient with appropriate software
• Demonstrated ability to multitask and prioritize competing demands/work load
• Proven flexibility and adaptability

Responsibilities

• Research and addresses issues, track metrics and maintain reports and documentation related to quality and compliance activities.
• Lead quality and compliance processes and ensure appropriate execution and completion.
• Lead smaller projects and/or some process/quality improvement initiatives.
• Communicate with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).
• Mentor staff and serve as a team lead for group projects or process improvement initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees