Senior QA Audit Lead, Clinical R&D (GCP/GLP/GVP)

Akebia Therapeutics; Waltham (MA); Hybrid; USD 160.000 - 198.000; Vollzeit

Zusammenfassung

Akebia Therapeutics in Waltham, MA is seeking an Associate Director, Research and Development Quality Assurance to provide technical leadership across GCP, GPP, GLP and GVP areas within Clinical Development, Global Medical Affairs, and Drug Safety.

You will collaborate with internal and external partners to ensure inspection readiness, drive CAPAs, and support regulatory inspections, with a focus on sustainable compliance.

Qualifikationen

• Bachelor's degree in life science and 8+ years of experience in QA for clinical development.
• Strong knowledge of GCP, GLP, GVP and regulatory guidelines.
• Experience leading audits and coordinating with multiple stakeholders.

Aufgaben

• Provide technical leadership in GCP, GPP, GLP, and GVP compliance.
• Develop and execute audit plans for clinical programs.
• Oversee audits and manage corrective actions.
• Support regulatory inspections and interdepartmental collaboration.

Kenntnisse

GCP compliance

GLP auditing

Quality assurance leadership

Regulatory compliance

Ausbildung

Bachelor's degree in life science

Tools

MS Word

Excel

PowerPoint

SharePoint

Jobbeschreibung

Akebia Therapeutics in Waltham, MA is seeking an Associate Director, Research and Development Quality Assurance to provide technical leadership across GCP, GPP, GLP and GVP areas within Clinical Development, Global Medical Affairs, and Drug Safety.

You will collaborate with internal and external partners to ensure inspection readiness, drive CAPAs, and support regulatory inspections, with a focus on sustainable compliance.