Senior Compliance Specialist (FSP), Remote (US)

Thermo Fisher Scientific•Wilmington, NC

7d•Remote

About The Position

The Senior Compliance Specialist executes quality and compliance strategies and initiatives across the organization to support the delivery of high-quality clinical research programs. This role manages the tracking, reporting, and documentation of quality and compliance activities, leads quality processes, and supports process improvement initiatives. The Senior Compliance Specialist serves as a project lead for assigned initiatives, mentors colleagues, and collaborates across functional teams to ensure compliance with regulatory requirements, internal quality standards, and client expectations.

Requirements

Bachelor's degree or equivalent combination of relevant education, training, and experience.
Previous experience that provides the knowledge, skills, and abilities to perform the role (comparable to 4+ years of relevant experience) or an equivalent combination of education, training, and experience.
Comprehensive knowledge of ICH GCP and other applicable clinical research regulations and guidelines.
Proven project management experience managing clinical trial delivery activities and cross-functional initiatives.
Extensive knowledge of the clinical trial process.
Excellent oral and written communication skills.
Strong organizational and time-management skills with the ability to manage multiple priorities.
Demonstrated problem-solving and analytical skills.
Excellent attention to detail.
Strong computer skills with the ability to quickly learn new software applications.
Ability to work independently while collaborating effectively within cross-functional teams.
Proven flexibility, adaptability, and sound judgment when managing competing priorities.
Experience mentoring colleagues and leading project or process improvement initiatives.

Responsibilities

Lead quality and compliance processes and ensure activities are executed and completed according to established timelines and quality standards.
Research, investigate, and resolve quality and compliance issues while tracking metrics, maintaining reports, and managing required documentation.
Coordinate with cross-functional teams to support compliance-related activities, including client audits, CAPA management, procedural documentation, and quality initiatives.
Lead smaller projects and selected process or quality improvement initiatives to enhance operational effectiveness.
Maintain compliance tracking tools, reports, and supporting materials while identifying trends and opportunities for continuous improvement.
Mentor team members and serve as a project lead for group initiatives and process improvement activities.
Represent the department as a primary point of contact on assigned projects and collaborate with internal and external stakeholders to support compliance objectives.
Apply comprehensive knowledge of ICH GCP and applicable regulations to support clinical development programs and ensure quality standards are maintained.