QA Lead Sr. Manager

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 bachelors 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. xywuqvp

Application Deadline - June 3, 2026

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