Senior Director, R&D Quality Assurance & Compliance

Akebia Therapeutics, Inc.; Waltham (MA); Hybrid; USD 239,000 - 295,000; Full time

Benefits offered by this job

Health care

Vision

Dental

Retirement plan

PTO

Job summary

Akebia Therapeutics, Inc. in Waltham, MA seeks a RQA Senior Director to lead day-to-day GCP/GLP/GVP Quality Operations, set strategic goals, manage budgets, hire, and develop a high-performing team.

The role reports to the VP/SVP of Quality and interacts with regulatory agencies to ensure compliant trials from first-in-human through marketing authorization. Responsibilities include coaching, cross-functional collaboration across Clinical Development, Operations, Safety, and Non-clinical teams;

Qualifications

• 10+ years in pharma/biotech GCP/GVP/GLP quality environments.
• 8+ years direct and indirect management experience.
• Bachelor’s degree in a scientific discipline required.

Responsibilities

• Lead day-to-day GCP/GLP/GVP Quality Operations and strategic objectives.
• Budgeting, hiring, team development, and cross‑functional collaboration.
• Ensure compliance with GCP/GLP/GVP regulations and ICH guidelines.
• Provide regulatory interpretation and escalate critical risks to Senior Leadership.
• Oversee vendor quality agreements and inspection readiness preparations.
• Support annual Quality Assurance budget development and management.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Budgeting

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Job description

Akebia Therapeutics, Inc. in Waltham, MA seeks a RQA Senior Director to lead day-to-day GCP/GLP/GVP Quality Operations, set strategic goals, manage budgets, hire, and develop a high-performing team.

The role reports to the VP/SVP of Quality and interacts with regulatory agencies to ensure compliant trials from first-in-human through marketing authorization. Responsibilities include coaching, cross-functional collaboration across Clinical Development, Operations, Safety, and Non-clinical teams;