Sr. Director, Research and Development Quality Assurance

Akebia Therapeutics•Waltham, MA

39d•$239,153 - $295,424•Hybrid

About The Position

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

Requirements

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.

Nice To Haves

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 the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
Ability to travel approximately 25% to various meetings including overnight trips. Some international travel may be required.

Responsibilities

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 escalate 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