GCP Compliance and Process Lead FSP
GCP Compliance and Process Lead FSP
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Job Summary
As the GCP Compliance and Process Lead at Thermo Fisher Scientific you will play a pivotal role in driving worldclass quality and compliance strategies. This is an exceptionally outstanding opportunity to influence and improve our healthcare operations ensuring flawless of regulatory standards. Your expertise will be crucial in determining and successfully implementing advanced quality assurance processes.
Key Responsibilities
- Identify develop and implement quality and compliance strategies across the organization promoting advanced regulatory compliance standards.
- Facilitate and manage crossfunctional teams GCP inspection readiness activities throughout the study lifecycle.
- Lead internal activities to ensure compliance with quality assurance processes standards and global regulatory guidelines.
- Embed realtime inspection readiness strategies into daily operations collaborating with study teams.
- Provide justintime mentorship on key operating model processes and required documentation prioritizing realtime inspection readiness.
- Manage and guide teams on inspection readiness planning developing and maintaining readiness plans and tools.
- Facilitate the development of key inspection deliverables including functional presentations and study team preparation for audits.
- Ensure highquality deliverables for global studies by guiding adherence to operational processes and documentation.
- Champion proactive prioritization of inspection readiness focusing on GCP process excellence.
- Engage with subject matter experts in inspection readiness activities and studylevel risk assessments.
- Coordinate and manage TMF performance and processes ensuring compliance and inspection readiness.
- Lead and participate in meetings for assigned projects ensuring effective communication and addressing customer concerns.
- Maintain project management documentation including plans timelines and progress reports.
- Coordinate activities to enable study team readiness for internal audits and regulatory inspections.
- Manage functional teams during inspections collaborate with SMEs and ensure timely followup.
Qualifications
- Good understanding of clinical trial processes related to sponsor and CRO activities including but not limited to sponsor oversight issue management site management and clinical monitoring
- Minimum of 6 years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of drug development clinical trial management and/or GCP compliance processes
- Proven awareness of sponsor oversight requirements and regulations
- Experience with CROs and outsourced clinical trial activities sponsor experience preferred
- Experience in problem solving negotiations and collaborative team building with non direct reports and other stakeholders is required
- Solid knowledge of regulatory requirements governing clinical trials industry best practices and related standard and documentation requirements
- Bachelors degree preferred or commensurate with experience
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use project management and presentations
- Valid drivers license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Domestic/international travel 520 may be required
Inclusion and Collaboration
At Thermo Fisher Scientific we value diverse experiences backgrounds and perspectives. Our inclusive culture fosters collaboration and innovation empowering each team member to contribute to our mission of advancing science and healthcare.
Employment Type
Full-Time
