The QA Lead oversees quality issues in the QMS, tracks case timeliness, supports teams in CAPA creation, and ensures effective communication of quality matters.
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.
Top Skills
Capa
GCP
Gxp
Qms
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