Associate Director, Research Quality Assurance New Waltham, Massachusetts, United States

Associate Director, Research Quality Assurance

Waltham, Massachusetts, United States

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 recently relocated to Waltham, MA. 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 Associate Director, Research and Development Quality Assurance provides technical leadership in programs managed by the Clinical Development, Global Medical Affairs organizations, and process managed by Drug Safety and Nonclinical Development. This position has the understanding of the regulatory requirements, experience, leadership, communication skills and business acumen to conduct responsibilities independently.

Key areas of accountability for this role are to provide professional expertise and strong technical leadership in Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) and applicable regulations and guidance and to proactively identify compliance issues/risks in assigned programs.

Primary responsibilities include but are not limited to: liaise with various internal R&D functions and external groups including contract auditors, clinical vendors and investigator sites in an effort to ensure a high level of quality and consistency across the studies; contribute to the audit strategy; assist project teams in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.

Essential Functions & Duties

Compliance Support

• Serve in an advisory/consultative role in compliance related matters for clinical programs/projects and supports project team in identifying and implementing corrective and preventive actions
• Supports project team to be inspection ready with a culture of sustainable compliance
• Performs program specific investigations to identify root cause of compliance issues and provides the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management
• Assists with continuous process improvement of the Clinical Quality system and RQA processes
• Support vendor qualification and internal audit program
• Escalate signals to RQA Management
• Provide consultation on, and interpretation of, regulations, guidance documents and industry standards.
• Provide support on Quality Issues to ensure appropriate investigation, root cause analysis and corrective and preventative actions.

Create and Execute on Audit Plans

• Develop the audit strategy for clinical programs
• Lead the execution of the audit activities associated with GCP, GPP, GLP and GVP to meet applicable regulatory requirements
• Collaborate with key stakeholders from program teams, audit coordinators and/or other QA colleagues to ensure audit plan execution
• Ensure the corrective and preventative actions are appropriate and completed in a timely manner
• Oversee the timely development and distribution of audit reports and follow up actions
• Assist in the review and identification of potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation
• As appropriate, upscale issues of critical noncompliance and/or lack of urgency in remediation to senior management

Management

• Provides oversight to auditors contracted to provide auditing services for assigned programs
• Coordinates activities with other operational groups, as required
• Oversees the timely development and distribution of audit reports and follow up actions

Regulatory Agency Inspection Support

• Assist with development and manages the strategies for the preparation, hosting, and responses to regulatory agency inspections for GCP/GVP/GLP/Sponsor.

Basic Qualifications

• Bachelor's degree in life science
• 8+years of experience
• GCP/GLP compliance and auditing experience

Preferred Qualifications

• The ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP, GVP, and/0r GLP auditing.
• Extensive knowledge and/or awareness of FDA GCP and Part 11 regulations, EMA and MHRA regulations, ICH Guidelines and European Clinical Trials Directive, 21 CFR part 58, EU PV Modules and an understanding of their application in the field.
• Strong leadership skills, and ability to inspire
• Collaborative team player with the ability to think and act quickly and identify creative solutions to complex problems.
• Strong judgment, project management and decision-making
• Strong technical writing Ability to write briefing documents, quality positions, investigations, audit reports and SOPs.
• Strong attention to detail with the ability to articulate quality related risks and potential
• Strong knowledge of MS Word, Excel, PowerPoint, SharePoint &
• Excellent communication and interpersonal
• Demonstrates ability to manage contract auditors across multiple
• Knowledge of regulatory guidelines in different geographic
• Influences without authority, in a matrix
• Requires a high degree of problem-solving ability; understanding objectives and processes across R&D functions and when escalation is necessary.
• Domestic and International travel required 15%

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.

$159,939 - $197,571 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:

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Akebia Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A \"recently separated veteran\" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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