Associate Director, Research Quality Assurance

Nearing 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.

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.

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, elevate issues of critical…