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?

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, escalate 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 - proven experience managing and driving sponsors and CROs
• Experience supporting and leading study teams
• Examples of creating and managing audits for ongoing and future studies
• Experience in managing, appraising, and potentially selecting vendors for current and future studies

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.
• Mature, problem-solving mindset, exhibits judgement and realistic understanding of the issue.
• Strong leadership skills, and ability to inspire colleagues.
• 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 skills.
• Strong technical writing skills. 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 impact.
• Strong knowledge of MS Word, Excel, PowerPoint, SharePoint & Outlook.
• Excellent communication and interpersonal skills.
• Demonstrates ability to manage contract auditors across multiple geographies.
• Knowledge of regulatory guidelines in different geographic regions.
• Influences without authority, in a matrix environment.
• 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%

Compensation:

Targeted Base: $155,812-$192,473*

*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.

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 characteristics protected by applicable law.