Director, Head of GCP/GVP/GLP Quality

Quality Assurance

This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, "magnet not mandate" approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs.

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

Job Summary:

The Director and Head of GCP/GVP/GLP Quality is a leadership role 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.

Essential Duties and Responsibilities

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.

Basic Qualifications:

* 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.

Preferred Qualifications:

* 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.

Compensation:

Targeted Base: $199,555-$246,510

*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.