Maintenance Clerk

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?

The RQA 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 Chief Technical Officer (CTO) or Sr. Vice President (SVP)/Vice President (VP) of Quality.

The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The RQA Director will develop strong relationships, collaborate, and interact with GCP/GVP/GLP suppliers, Akebia 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.

This individual will collaborate and 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. The incumbent will directly oversee and interface on with internal and external partners.

The incumbent will also oversee, assess and directly work to continuously execute and improve Akebia RQA processes. Specifically, the incumbent must have the ability to execute tasks independently in a rapidly growing, fast-paced environment, representing Quality Assurance in a GCP-focused team setting and managing Quality-related activities related to clinical studies, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Akebia’s clinical stakeholders and act as a catalyst for continuous process improvement.

This 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.

• Provide strategic direction to the R&D Quality organization through goal alignment, proposing continuous improvement initiatives, and educating the organization on best-in-class practices both with Akebia Quality and across the company.
• Drive achievement of strategic Quality objectives through leadership & coaching of direct reports and cross-functional influence at the senior level.
• 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 escape 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.
• Administers…