Akebia Therapeutics

Develops CKD anemia therapies

Senior Director - Research and Development Quality Assurance

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeWaltham, MA, USA$239.2k - $295.4k

About the Job

Requirements

A bachelor's degree in a scientific discipline is required.
At least 10 years of progressively responsible experience in pharmaceutical or biotechnology GCP, GVP, and GLP-related quality environments.
At least 8 years of direct and indirect management-level experience.
In-depth working knowledge of applicable GCP, GLP, and GVP regulations and guidelines.
In-depth working knowledge of non-clinical and clinical research processes.
Ability to efficiently use provided computer hardware and software to plan, manage, conduct, and track deliverables and communicate with internal and external team members.
Ability to travel approximately 25% to meetings, including overnight trips; some international travel may be required.

Responsibilities

Manage day-to-day GCP, GLP, and GVP Quality Operations, including goal setting, budgeting, hiring, team development, strategic execution, and oversight of the Research and Development Quality Assurance operational strategy.
Drive achievement of strategic Quality objectives through leadership and coaching of direct reports and cross-functional influence at the senior level.
Develop relationships and collaborate with Clinical Development, Clinical Operations, Statistics and Data Management, Drug Safety and Pharmacovigilance, Non-clinical, and management teams to accomplish company objectives.
Partner with external collaborators to ensure processes, systems, and activities protect study subjects’ rights, safety, and welfare.
Ensure GCP, GLP, and GVP projects and programs comply with current regulations and ICH guidelines.
Provide consultation on and interpretation of regulations, guidance documents, and industry standards.
Communicate and escalate critical risks to senior leadership, provide objective representation of issues, conduct robust root cause analysis, and implement effective corrective and preventive actions for nonconformances.
Ensure Quality Agreements are established as necessary with key GCP, GLP, and GVP vendors.
Lead internal and external inspection-readiness preparations, including hosting and interacting with regulatory agencies on GCP, GLP, and GVP matters.
Assist in developing and managing the annual Quality Assurance budget.
Oversee and assess Research and Development Quality processes and work to continuously improve them.
Continue developing the GCP, GLP, and GVP Quality Assurance function and ensure high-quality execution of non-clinical and clinical trials from first-in-human through commercial marketing authorization.
Interact with regulatory agencies regarding GCP, GVP, and GLP matters.

Desired Qualifications

An advanced degree in a scientific discipline is strongly preferred.

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 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.

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 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

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.

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.

Targeted Base Salary

$239,153—$295,424 USD

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.

Targeted Base Salary 239153 - 295424 USD

About the Company

Akebia Therapeutics

Develops CKD anemia therapies

Akebia Therapeutics focuses on developing and commercializing therapies for chronic kidney disease (CKD), especially anemia related to CKD. Its lead product candidate, vadadustat, is in global Phase 3 trials. The company conducts research, clinical development, and strategic partnerships to bring therapies to market, generating revenue from product sales, licensing, and collaborations. Akebia's goal is to improve the quality of life for CKD patients by providing effective treatments through a science-driven biopharmaceutical approach based in Cambridge, MA.

Company size: 201-500
Company stage: IPO
Headquarters: Cambridge, MA
Founded: 2007

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