Thermo Fisher Scientific

GCP Compliance and Process Lead

Thermo Fisher Scientific

Remote
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you passionate about ensuring compliance and streamlining processes? Do you have experience with GCP regulations and a drive for continuous improvement? Thermo Fisher Scientific is seeking a dedicated and knowledgeable individual to join our team as the GCP Compliance and Process Lead. In this role, you will play a critical role in maintaining our high standards of compliance and efficiency in our clinical research operations. If you are detail-oriented, highly organized, and have strong communication skills, we encourage you to apply for this exciting opportunity!

  1. Develop and maintain a thorough understanding of GCP regulations and guidelines to ensure compliance within the organization.
  2. Lead the implementation of GCP processes and procedures to streamline operations and improve efficiency.
  3. Conduct regular audits and reviews to identify any potential compliance issues and work with relevant teams to address and resolve them.
  4. Collaborate with cross-functional teams to develop and implement training programs on GCP regulations and compliance requirements.
  5. Stay updated on changes in GCP regulations and communicate any updates or changes to the appropriate teams.
  6. Act as a subject matter expert on GCP compliance and provide guidance and support to team members.
  7. Identify areas for improvement in current processes and develop solutions to enhance compliance and efficiency.
  8. Develop and maintain documentation and records related to GCP compliance for internal and external audits.
  9. Communicate and collaborate with external partners and vendors to ensure compliance and alignment with GCP regulations.
  10. Continuously monitor and evaluate GCP compliance metrics to identify opportunities for improvement and make recommendations to management.
Where is this job?
This job opening is listed as 100% remote
Job Qualifications
  • Bachelor's Degree In A Relevant Field Such As Life Sciences, Engineering, Or Computer Science.

  • Minimum Of 5 Years Of Experience In A Compliance Or Quality Role Within The Pharmaceutical Or Biotech Industry.

  • Strong Knowledge And Understanding Of Gcp Regulations And Guidelines, Including Fda And Ich Guidelines.

  • Experience Developing And Implementing Gcp Compliance Processes And Procedures.

  • Excellent Communication And Leadership Skills, With The Ability To Effectively Train And Mentor Team Members On Gcp Compliance.

Required Skills
  • Quality Assurance

  • Communication Skills

  • Project Management

  • Data Analysis

  • Auditing

  • Risk assessment

  • Process Management

  • Regulatory compliance

  • Training and Development

  • Sop Creation

  • Gcp Guidelines

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Empathy

  • Decision-making

Compensation

According to JobzMall, the average salary range for a GCP Compliance and Process Lead is between $120,000 and $160,000 per year in the United States. This may vary depending on the specific company, location, and level of experience. Some companies may also offer additional benefits and bonuses.

Additional Information
Thermo Fisher Scientific is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMarch 19th, 2025
Apply BeforeMay 22nd, 2025
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About Thermo Fisher Scientific

Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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