Thermo Fisher Scientific

Senior Compliance Specialist (FSP), Remote (US)

Thermo Fisher Scientific • $90K — $120K *
US-AnywhereRemote in North Carolina, US
Healthcare
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent education/training/experience
  • 4+ years of relevant experience or equivalent combination of education and experience
  • Comprehensive knowledge of ICH GCP and clinical research regulations
  • Proven project management experience within clinical trials
  • Strong organizational, communication, and analytical skills

Responsibilities

  • Lead and ensure execution of quality and compliance processes
  • Research and resolve quality and compliance issues, maintaining documentation
  • Coordinate cross-functional compliance activities, including audits and CAPA management
  • Lead process improvement initiatives to enhance operational effectiveness
  • Maintain compliance tracking tools and identify trends for improvement
  • Mentor team members and lead project initiatives
  • Act as primary point of contact for assigned projects and collaborate with stakeholders

Benefits

  • Comprehensive training and professional development opportunities
  • Supportive workplace culture fostering collaboration and teamwork
  • Exposure to high-quality clinical research programs
  • Opportunity to take on leadership roles and mentor others
  • Flexible working conditions with occasional travel opportunities
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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.

What You'll Do
  • 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.

Education & Experience 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.
  • In some cases, an equivalency consisting of appropriate education, training, and/or directly related experience will be considered sufficient to meet the requirements of the role.


Knowledge, Skills & Abilities
  • 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.

Working Conditions & Environment
  • Work is performed primarily in an office environment with exposure to standard office equipment.
  • Occasional travel to client sites or company offices, both domestic and international, may be required.
  • Frequent computer use and prolonged periods of sitting throughout the workday.
  • Ability to work independently with minimal supervision while managing multiple priorities and meeting deadlines.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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