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

Work Schedule

Environmental Conditions

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.

Qualification Requirements:

Education 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.

Experience Requirements:

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.

A t 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.

Knowledge, Skills and Abilities:

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

0-25% travel may be required.

Location: Fully remote, ideally East Coast . Relocation assistance is NOT provided.

*Must be able to pass a comprehensive background check, which includes a drug screening.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.