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 .