Director, Research and Development Quality Assurance (RQA)

Director, Research and Development Quality Assurance (RQA)

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Quality Assurance

Cambridge, MA

ID : 24R-28

Full-Time / Regular

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.

Essential Functions and Duties

• 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 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.
• Administers performance reviews, guides development plans and set goals for GCP / GLP / GVP department staff in alignment with company goals and strategic plans.
• Assist in the development and management of the annual budget for Quality Assurance

Basic Qualifications

• Bachelor's degree in a scientific discipline is required. An advanced degree in a scientific discipline is strongly preferred.
• 8+ years of progressive responsibility in pharmaceutical / biotech GCP, GVP and GLP-related Quality environments.

Preferred Qualifications

• 8+ years direct and indirect management level experience required.
• Excellent written and oral skills required.
• In-depth working knowledge of the applicable GCP / GLP / GVP regulations and guidelines.
• In-depth working knowledge of Quality responsibilities related to the non-clinical and clinical research process, clinical study design, clinical study oversight and execution.
• Communication Skills : Must professionally, clearly, concisely and consistently communicate to external and internal customers.
• Leadership : Must be able to lead, manage, and build a GCP / GLP / GVP team in a fast-paced, growing environment.
• Must be able to prioritize work effectively to ensure the team can meet department and corporate timelines related to clinical trials associated with Akebia's growth strategy and pipeline requirements.
• Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track clinical sstudy 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.
• Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
• Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
• Leads by example and highly collaborative with the proven ability to work in a cross-functional team.

Compensation :

Targeted Base : 185,364-228,979*

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, a ll 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.

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

COVID 19 Vaccination : All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.

Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship.

Please note that it is unlikely that accommodations can be granted for customer-facing positions.

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.