Senior Compliance Manager-- fully remote!

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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?

Develops and executes quality and compliance strategies and initiatives across the organization, including promoting awareness of quality and regulatory compliance standards and trends. Oversees governance and compliance management processes including quality events, serious breach events and suspected scientific misconduct events. Develops and maintains quality and compliance guidance/reference materials and tools and provides expertise to advance the vision of the department.

Leads quality and compliance processes and engages with cross-departmental staff to ensure appropriate execution and completion (e.g., quality events, serious breach events, suspected scientific misconduct events, supports inspections and audits)

Develops guidance and reference information, repositories and communication channels (e.g., requests for information/ proposals (RFI/RFP), policies, procedures, guidance documents or quality management systems training)

Creates formal networks with key contacts across the department.

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 10+ years’) or equivalent combination of education, training, & experience.

Experience working with GCP is required.

Demonstrated ability to use critical thinking is required.

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.

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 sc