Summary of Responsibilities:
- Contributes to generation of global QA policies on interpretation or application.
- Provides subject matter GxP expertise and influences the ED/CS/CDS organization by providing guidance and client/authority facing support on specific regulatory topics and Quality Issues.
- Hosting of external audits/inspections e.g., regulatory inspections, strategic clients.
- Supports clients in making regulatory (strategic) decisions/ issue resolution for study problems.
- Manages the QA-to-QA relationship with assigned key client(s).
- Participates in client JOC or governance meetings.
- Manages the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g., Monthly Reports, Site Quality Review, Liaison meetings) for assigned clients.
- Provides support to Compliance Lead and Sr. management as a contributor or leader of internal functional QA RCQA initiative.
- 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):
- 6 years in regulatory environment (experience in GXP roles).
- Ability to manage client responsibilities.
- Report and communicates key quality information to Sr. Managers and QA.
- Effectively lead and communicate critical issues during client meetings.
- Ability to manage difficult conversations and meetings with clients.
- Detailed knowledge of specific regulations/multiple regulations.
- Ability to influence and negotiate.
- Excellent communication, interpersonal, planning, and organizational skills.
- Ability to mentor and lead other colleagues within the group.
Physical Demands/Work Environment:
- Some overtime and weekend work may be required.
- Travel required.
Application Deadline - June 3, 2026
Learn more about our EEO & Accommodations request here.
