QA Lead (GCP)

Job description

Summary of Responsibilities: • Works with internal teams to progress quality issues in QMS. • Tracks timeliness of cases in QMS. • Supports teams in creation of CAPAs. • Maintains strong working knowledge of QMS. • Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications. • Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI. • 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 (Minimum Required): • 8 years in regulatory environment (experience in GXP roles). • Strong understanding of QMS and CAPA process. • Ability to work well within a team environment. • Convey key details of quality issues internally. • Communicate quality issue summary to clients where applicable. • Knowledge of GCPs/GxPs. Preferred Qualifications Include: • Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Physical Demands/Work Environment: • Travel may be required. • Office-Based (Hybrid), as requested by the line manager. Learn more about our EEO & Accommodations request here .