Sr Compliance Specialist, GxP Non-Compliance-- fully remote!

Thermo Fisher Scientific • Morrisville, NC

1d • Remote

About The Position

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and supporting our customers’ medical related inquiries. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us. What will you do in this role? Researches and addresses issues, tracks metrics and maintains reports and documentation related to quality and compliance activities. Leads quality and compliance processes and ensures appropriate execution and completion. Leads smaller projects and/or some process/quality improvement initiatives. Communicates 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). Mentors staff and serves as a team lead for group projects or process improvement initiatives.

Requirements

• Bachelor's degree is required. 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.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience working with GCP is required.
• Demonstrated ability to use critical thinking is required.
• Expertise in applicable GxP and appropriate regional regulations
• Extensive knowledge of the clinical trial process
• Expert knowledge of SOPs and WPDs
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong training/mentoring experience of staff on a variety of process/topics
• Strong attention to detail
• Effectively works independently or in a team environment
• Highly developed problem solving, risk assessment, and impact analysis skills
• Strong negotiation and conflict management skills
• Strong organizational and time management skills including ability to multitask and prioritize competing demands/work load
• Strong computer skills; ability to learn and become proficient with appropriate software
• Proven flexibility and adaptability
• Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

• At least 2 years in Clinical Quality, GCP Compliance or related is preferred.
• Experience in CAPA, root cause analysis, and deviation management is preferred.
• Demonstrated ability to communicate complex compliance issues clearly and effectively is preferred.
• Comfortable working in a matrix organization and managing cross-functional customers is preferred.
• Prior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) is preferred.

Responsibilities

• Researches and addresses issues, tracks metrics and maintains reports and documentation related to quality and compliance activities.
• Leads quality and compliance processes and ensures appropriate execution and completion.
• Leads smaller projects and/or some process/quality improvement initiatives.
• Communicates 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).
• Mentors staff and serves 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