Overseeing Quality Issue Management, ensuring GCP compliance, and providing expert QA support across clinical development teams
Collaborating 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
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

A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience)
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
Knowledge of GCPs/GxPs

Flexibility in working outside office may be needed to work with global team and clients
Occasional travel required

QA Lead Manager

Key skills