QA Lead Manager

The QA Lead Manager is responsible for overseeing Quality Issue Management, ensuring GCP compliance, and providing expert QA support across clinical development teams. This role partners closely with cross‑functional stakeholders to investigate quality issues, drive effective CAPA development, support audit and inspection readiness, and maintain current GCP regulatory knowledge. The QA Lead Manager also plays a key role in fostering a strong quality culture and ensuring operational excellence throughout the organization.
Summary of Responsibilities:
Quality Issue Management - provide QA support and oversight by collaboration with business functions to conduct thorough investigations and ensure appropriate CAPAs are identified, developed, implemented effectively.
Support development of CAPA plans arising from internal audits, sponsor audits, and regulatory inspections.
Maintain up‑to‑date knowledge of GCP regulations and relevant global/local regulatory expectations, and communicate updates to internal teams as needed.
Provide QA consultation and compliance guidance to study teams and cross‑functional partners.
Lead or support inspection readiness activities, including training, process walkthroughs, documentation reviews, and risk‑based preparation.
Provide inspection management support during regulatory inspections
Facilitate regular meetings with internal teams and sponsors to discuss quality issues, trends, risks, and continuous‑improvement opportunities.
Contribute to strengthening quality culture, process improvement, and optimization of quality systems and SOPs.
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):
5 years in regulatory environment (experience in GXP roles).
Strong understanding of QMS and CAPA processes.
Ability to manage client responsibilities.
Report and communicates key quality information to Sr. Managers and QA.
Able to work effectively within a team environment.
Able to communicate effectively during client meetings
Knowledge of GCPs/GxPs.
Physical Demands/Work Environment:
Flexibility in working outside office may be needed to work with global team and clients
Occasional travel required.