Jobs at Akebia Therapeutics

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. 

• 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

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 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.