Senior Director, QA: GCP/GLP/GVP Quality Leader

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

Job summary

Akebia Therapeutics, Inc. is seeking a RQA Senior Director to lead day-to-day Quality Operations for GCP/GLP/GVP, shaping strategy, budgeting, hiring, and cross-functional collaboration. The role includes oversight of QA processes from non-clinical to clinical trials and interactions with regulators.

The position reports to VP/SVP of Quality and requires strong leadership, regulatory acumen, and the ability to travel ~25% for meetings and inspections.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Minimum of 10 years in pharmaceutical/biotech GCP, GVP and GLP quality environments.
• 8+ years management experience (direct and indirect).

Responsibilities

• Drive strategic Quality objectives through leadership and coaching of direct reports.
• Collaborate with Clinical Development, Operations, Statistics & Data Management, Drug Safety, and Non-clinical teams.
• Maintain compliance with GCP/GLP/GVP regulations and ICH guidelines.
• Provide regulatory interpretation and communicate risks to Senior Leadership.
• Lead inspection readiness and support regulatory inspections.
• Assist in annual Quality Assurance budget development.

Skills

GCP/GxP knowledge

Quality leadership

Regulatory interpretation

Cross-functional collaboration

Budget management

Education

Bachelor's degree in science

Job description

Akebia Therapeutics, Inc. is seeking a RQA Senior Director to lead day-to-day Quality Operations for GCP/GLP/GVP, shaping strategy, budgeting, hiring, and cross-functional collaboration. The role includes oversight of QA processes from non-clinical to clinical trials and interactions with regulators.

The position reports to VP/SVP of Quality and requires strong leadership, regulatory acumen, and the ability to travel ~25% for meetings and inspections.