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.
Skills Required
- A minimum of a bachelor's degree in Life Sciences
- 6 years in regulatory environment
- Ability to influence and negotiate
- Excellent communication and organizational skills
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
