Sr. Director, Research and Development Quality Assurance

Akebia Therapeutics, Inc.; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Akebia is seeking a Senior Director of Regulatory Quality Assurance to lead GCP/GLP/GVP Quality Operations across non-clinical and clinical programs from early phases through commercialization. The role requires strong leadership, strategic quality planning, and collaboration with cross-functional partners in a hybrid work setting based in Waltham, MA, with travel scheduled.

The candidate will guide risk mitigation, CAPA processes, and regulatory interactions while managing both internal and

Qualifications

• Bachelor’s in a scientific discipline required.
• 10+ years in pharmaceutical/biotech GCP, GVP, GLP environments.
• 8+ years of management experience.

Responsibilities

• Oversee quality management across GCP/GLP/GVP operations.
• Develop and implement strategic quality objectives.
• Foster cross-functional collaboration to ensure quality.
• Ensure regulatory compliance and inspection readiness.
• Interact with regulatory agencies as needed.
• Lead and coach domestic and external teams in quality initiatives.

Skills

Quality leadership

Regulatory interactions

Cross-functional collaboration

Risk mitigation

Education

Bachelor’s in a scientific discipline

Job description

Role: Senior Director of RQA

responsible for leading GCP/GLP/GVP Quality Operations at Akebia, ensuring high-quality execution of non-clinical and clinical trials from early phases to commercialization.

Responsibilities

• oversee quality management
• develop and implement strategic quality objectives
• foster cross-functional collaboration
• ensure regulatory compliance
• manage inspection readiness
• interact with regulatory agencies
• lead and coach domestic and external teams
• develop strong relationships across departments and vendors
• guide risk mitigation and CAPA processes

Requirements

• bachelor’s in a scientific discipline
• 10+ years in pharmaceutical/biotech GCP, GVP, GLP environments
• 8+ years of management experience

Preferred

• advanced scientific degree
• comprehensive knowledge of GCP/GLP/GVP regulations
• understanding of clinical and non-clinical research processes

High-Value: oversight of quality in clinical development, regulatory interactions, inspection readiness, and strategic quality leadership.

Work setup

hybrid model based in Waltham; travel approximately 25%, including international trips.