Summary Of Responsibilities
- Tracking and Progression of Quality Issue.
- Development and delivery of training (to operational groups).
- Provide advice and guidance on aspects of quality and compliance.
- Provide consultation to the operational team on quality issues workflow.
- Cross-site QA and operational relationship, provide recommendations for improving compliance and / or efficiency.
- Work with operational management to support Quality topics and / or working on projects with QA team on other sites [showing development of collaboration skills].
- Manage local Quality initiatives aimed at improving compliance and / or efficiency of the local QA organization.
- 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)
Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience).Experience may be substituted for education.Experience (Minimum Required)
6 years in regulatory environment (experience in GXP roles).Experienced GXP auditor.Able to influence QA strategy.Ability to communicate with groups.Knowledge of multiple operational areas.Knowledge of industry quality systems / standards and ability to apply appropriate regulatory knowledge to multiple scenarios.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.
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Skills Required
Gxp, Regulatory Compliance, Quality Assurance