GLP Quality

Akebia Therapeutics•Cambridge, MA

4d•Hybrid

About The Position

This leadership role is responsible for both strategic and operational oversight of GCP, GVP, and GLP Quality activities. The responsibilities include goal setting, budget management, organizational design, talent acquisition and development, and execution of the Development Quality strategy at Akebia. This position serves as a member of the Quality Leadership Team and reports directly to the Vice President of Quality. This individual provides leadership and direction to ensure the effectiveness, compliance, and continuous improvement of Development Quality systems and processes across Research and Development. The role is accountable for advancing and maturing the GCP, GVP, and GLP Quality function, ensuring high-quality, compliant execution of nonclinical and clinical programs from first-in-human studies through marketing authorization and post-marketing activities, as applicable. The position represents Development Quality in interactions with global regulatory authorities and external partners on GCP, GVP, and GLP-related matters, including inspection readiness and direct support during regulatory inspections.

Requirements

Bachelor’s degree in a scientific discipline is required.
Minimum of 10 years of progressive experience in GxP Quality (GCP, GVP, and GLP) within the pharmaceutical or biotechnology industry, including demonstrated leadership responsibility.
Minimum of 8+ years of people management experience, including direct and/or matrix leadership.

Nice To Haves

An advanced degree (e.g. MS, PhD, PharmD) in a scientific discipline is strongly preferred.
Deep expertise in global GCP, GVP, and GLP regulations and guidance, including hands-on experience supporting regulatory inspections.
Comprehensive understanding of the drug development lifecycle, including nonclinical, clinical, and pharmacovigilance processes.
Demonstrated ability to apply risk-based quality principles and influence decision-making at senior levels.
Proficiency in quality systems, electronic platforms, and data tools to plan, manage, and track quality activities and deliverables.
Ability to travel approximately 25%, including domestic and international travel, as required.

Responsibilities

Drive the achievement of strategic Quality objectives through effective leadership, talent development, and coaching of direct reports, while influencing cross-functional stakeholders at the senior leadership level.
Build and maintain strong, collaborative relationships across key functions (e.g., Clinical Development, Clinical Operations, Biostatistics & Data Management, Pharmacovigilance/Drug Safety, and Nonclinical) to enable proactive quality oversight and execution of company objectives.
Establish and sustain effective partnerships with external collaborators and vendors to ensure robust quality systems, processes, and oversight mechanisms are in place to protect the rights, safety, and well-being of study participants.
Provide strategic oversight to ensure GCP, GVP, and GLP programs are conducted in compliance with applicable global regulations (e.g., FDA, EMA) and ICH guidelines.
Serve as a subject matter expert in the interpretation and application of GxP regulations, guidance documents, and industry best practices, providing risk-based, phase-appropriate quality guidance.
Proactively identify, communicate, and escalate critical quality and compliance risks to senior leadership, ensuring objective assessment, thorough root cause analysis, and timely, effective CAPA implementation.
Oversee the establishment and maintenance of Quality Agreements with GCP, GVP, and GLP vendors and partners, ensuring clear delineation of roles, responsibilities, and compliance expectations.
Lead and maintain a state of inspection readiness for regulatory authority inspections and partner audits, including direct interaction with global health authorities on GCP/GVP/GLP matters.
Oversee risk-based audit programs (internal and external), including vendor, system, and study audits, to ensure ongoing compliance and continuous improvement.
Drive continuous improvement initiatives within Development Quality systems and processes, leveraging inspection trends, audit outcomes, and industry insights.
Contribute to the development and management of the annual Quality Assurance budget, ensuring alignment with strategic priorities and resource needs.