Sr. Director, Research and Development Quality Assurance

Waltham, Massachusetts, United States

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?

Please note that our offices have recently relocated to Waltham. 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.

Job Summary

The RQA Senior Director is a strategic leadership role responsible for management of day-to-day GCP/GLP/GVP Quality Operations including, goal setting, budgeting, hiring, team development, strategic execution and oversight of the Akebia RQA operational strategy. This position will be a member of the Quality Leadership Team and will report to the Vice President (VP)/Sr. Vice President (SVP) of Quality.

This individual will oversee, assess, and directly work to continuously improve Research and Development Quality processes s is an opportunity to continue the development of the GCP/GLP/GVP QA function and ensure high quality execution of non-clinical and clinical trials from first in human through commercial marketing authorization.

This position will also be responsible for interactions with regulatory agencies in regard to GCP, GVP and GLP matters.

Essential Functions and Duties

• Drive achievement of strategic Quality objectives through leadership & coaching of direct reports and cross-functional influence at the senior level
• Develop strong relationships, collaborate, and interact with various departments (i.e., Clinical Development, Clinical Operations, Statistics & Data Management, Drug Safety and Pharmacovigilance, Non-clinical) and levels of management at Akebia to accomplish company objectives.
• Develop strong relationships and partner with external collaborators to ensure the appropriate processes, systems, and activities are in place to protect the rights, safety, and welfare of study subjects.
• Ensure GCP/GLP/GVP projects and programs are conducted in accordance with current GCP/GLP/GVP regulations and ICH guidelines.
• Provide consultation on, and interpretation of, regulations, guidance documents and industry standards.
• Communicate and escal critical risks to Senior Leadership: requires diplomatic and objective representation of the issue(s), robust root cause analysis and effective CAPA implementation for nonconformances.
• Ensure Quality Agreements are established, as necessary, with Akebia’s key GCP/GLP/GVP vendors.
• Lead inspection readiness preparations (internal and external) including hosting and interacting with regulatory agencies during inspections on GCP/GLP/GVP related matters.
• Assist in the development and management of the annual budget for Quality Assurance

Basic Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Minimum of 10 years of progressive responsibility in pharmaceutical/biotech GCP, GVP and GLP-related Quality environments.
• 8+ years direct and indirect management level experience required.

Preferred Qualifications

• An advanced degree in a scientific discipline is strongly preferred.
• In-depth working knowledge of the applicable GCP/GLP/GVP regulations and guidelines.
• In-depth working knowledge of the non-clinical and clinical research process.
• Must be able to efficiently utilize…