QA Lead Manager - GCP

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

We are currently seeking a QA Lead Manager, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.

This is a full-time, office-based position in Daytona Beach, Florida.

If you join us, you will work with some of the worlds leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

Summary of Responsibilities:

• Manages Quality Issues and CAPAs to resolution.
• Provides monthly report of activities to Sr. QA Manager/QA portfolio Manager.
• Oversees timely completion of CAPAs and QIs in QMS.
• Supports internal and external teams in completing investigations and creation of CAPAs.
• Maintains good working knowledge of GCP and knowledge of regulatory authority requirements and inspection support.
• Interacts with QA Lead Sr. Manager and above as required for quality issue case progression, issue escalations and client notifications.
• Supports QA lead Sr. Manager and above in pulling metric data, trending, and tracking of QIs for client metrics.
• Hosting of external audits/inspections e.g., regulatory inspections, strategic clients.
• Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• A minimum of a bachelor's degree in Life Sciences preferred (or equivalent Life Science experience).
• Experience may be substituted for education.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 5 years in regulatory environment (experience in GXP roles).
• Strong understanding of QMS and CAPA processes.
• Ability to manage client responsibilities.
• Report and communicates key quality information to Sr. Managers and QA.
• Able to work effectively within a team environment.
• Able to communicate effectively during client meetings.
• Knowledge of GCPs/GxPs.

Physical Demands/Work Environment:

• Some overtime and weekend work may be required.
• Travel required.

Learn more about our EEO & Accommodations request here.