Strategic Clinical Compliance Lead

ThermoFisher Scientific; Waltham (MA); Remote; GBP 70,000 - 110,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Compliance Manager to oversee audits, assess QA processes, and report findings. You will act as a subject matter authority on audits and support QA across the clinical development portfolio.

Responsibilities include conducting complex internal/external audits, root-cause analysis, issuing management reports, and mentoring staff. Strong knowledge of GxP, ICH guidelines, and clinical quality systems is essential.

Qualifications

• Thorough knowledge of applicable GxP and regional regulations.
• Extensive knowledge of the clinical trial process.
• Excellent oral and written communication skills using medical terminology.
• Training/mentoring experience.
• Strong attention to detail.

Responsibilities

• Conduct internal and external audits to ensure compliance with QA processes, standards, regulatory guidelines, and client obligations.
• Identify issues impacting quality and integrity of clinical research programs; determine root causes and develop corrective actions.
• Perform technical document reviews and GxP activities for clinical development programs as needed.
• Provide audit reports to management and stakeholders.
• Plan and deliver quality services for audits; lead process/quality improvement initiatives.
• Develop tools for tracking compliance activities and analyze trends.
• Mentor junior staff and serve as project lead for group projects.

Skills

GxP knowledge

Clinical trials

Communication skills

Leadership

Problem solving

Education

Bachelor's degree in life sciences

Tools

Veeva Vault

TrackWise

Job description

Thermo Fisher Scientific is seeking a Clinical Compliance Manager to oversee audits, assess QA processes, and report findings. You will act as a subject matter authority on audits and support QA across the clinical development portfolio.

Responsibilities include conducting complex internal/external audits, root-cause analysis, issuing management reports, and mentoring staff. Strong knowledge of GxP, ICH guidelines, and clinical quality systems is essential.