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About the role
- 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
Requirements
- 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
Benefits
- Flexibility in working outside office may be needed to work with global team and clients
- Occasional travel required
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GCP complianceCAPA processesQMSregulatory inspectionsinternal auditsrisk-based preparationdocumentation reviewsquality issue managementinvestigations
Soft Skills
collaborationcommunicationleadershipteamworkclient managementproblem-solvingorganizational skills