Senior QA Leader, Clinical Research & Compliance (Hybrid)

Akebia-Therapeutics-; Waltham (MA); Hybrid; USD 160,000 - 198,000; Full time

Benefits offered by this job

Health care

Vision care

Dental care

Retirement plan

PTO

Job summary

Akebia Therapeutics in Waltham, MA is seeking an Associate Director, Research and Development Quality Assurance to provide technical leadership in GCP, GPP, GLP and GVP compliance across Clinical Development, Global Medical Affairs, and Drug Safety. The role requires 8+ years of auditing experience and a bachelor’s degree in life sciences.

You will liaise with internal R&D teams, oversee audit planning and CAPA implementation, and drive continuous quality improvement while enabling teams to be

Qualifications

• Bachelor's degree in life science is required.
• 8+ years of experience in QA/regulatory compliance/auditing.
• Experience with GCP/GLP/GVP regulatory frameworks.

Responsibilities

• Advise on compliance matters for clinical programs and implement CAPAs.
• Develop and oversee audit plans for GCP/GPP/GLP/GVP.
• Lead audit execution and ensure timely remediation.

Skills

GCP auditing

GLP auditing

GVP auditing

Regulatory compliance

Leadership

Education

Bachelor's degree in life science

Tools

MS Word

Excel

PowerPoint

SharePoint

Job description

Akebia Therapeutics in Waltham, MA is seeking an Associate Director, Research and Development Quality Assurance to provide technical leadership in GCP, GPP, GLP and GVP compliance across Clinical Development, Global Medical Affairs, and Drug Safety. The role requires 8+ years of auditing experience and a bachelor’s degree in life sciences.

You will liaise with internal R&D teams, oversee audit planning and CAPA implementation, and drive continuous quality improvement while enabling teams to be