Associate Director, Research Quality Assurance

Akebia Therapeutics•Waltham, MA

20h•Hybrid

About The Position

The Associate Director, Research and Development Quality Assurance provides technical leadership for programs managed by Clinical Development and Global Medical Affairs, as well as processes managed by Drug Safety and Nonclinical Development. The role independently applies regulatory knowledge, experience, leadership, communication skills, and business acumen to provide expertise in GCP, GPP, GLP, and GVP and applicable regulations and guidance, and to proactively identify compliance issues and risks in assigned programs. The position partners with internal R&D functions and external groups—including contract auditors, clinical vendors, and investigator sites—to support consistent quality across studies. It contributes to audit strategy, helps project teams identify and implement corrective and preventive actions, and supports inspection readiness and sustainable compliance. The role also supports regulatory agency inspection preparation, hosting, and responses for GCP, GVP, GLP, and sponsor inspections. The role is based in Waltham, Massachusetts, with a flexible, “magnet not mandate” approach to in-office work and hybrid flexibility based on role and business needs. Domestic and international travel of 15% is required.

Requirements

Bachelor’s degree in life science.
At least 8 years of GCP/GLP compliance and auditing experience.
Ability to travel domestically and internationally 15%.
Strong leadership skills and ability to inspire.
Collaborative team-player skills and 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, including the ability to write briefing documents, quality positions, investigations, audit reports, and SOPs.
Strong attention to detail and ability to articulate quality-related risks and potential impacts.
Strong knowledge of MS Word, Excel, PowerPoint, and SharePoint.
Strong communication and interpersonal skills.
Ability to manage contract auditors across multiple assignments.
Ability to influence without authority in a matrix environment.
Strong problem-solving ability, understanding of objectives and processes across R&D functions, and judgment about when escalation is necessary.

Nice To Haves

Broad experience in product development, clinical operations, regulatory compliance, and GCP, GVP, and/or GLP auditing.
Extensive knowledge of and/or awareness of FDA GCP and Part 11 regulations, EMA and MHRA regulations, ICH Guidelines, the European Clinical Trials Directive, 21 CFR Part 58, and EU PV Modules, including understanding of their application in the field.

Responsibilities

Serve as an advisor and consultant on compliance matters for clinical programs and projects, and support project teams in identifying and implementing corrective and preventive actions.
Help project teams maintain inspection readiness and a culture of sustainable compliance.
Conduct program-specific investigations to identify root causes of compliance issues and provide metrics for tracking and trending and reporting to functional and senior management.
Support continuous improvement of the Clinical Quality system and RQA processes.
Support vendor qualification and the internal audit program.
Escalate signals to RQA management.
Interpret and provide consultation on regulations, guidance documents, and industry standards.
Support investigation of quality issues, root-cause analysis, and corrective and preventive actions.
Develop audit strategies for clinical programs.
Lead audit activities associated with GCP, GPP, GLP, and GVP to meet applicable regulatory requirements.
Collaborate with program teams, audit coordinators, and QA colleagues to execute audit plans.
Ensure corrective and preventive actions are appropriate and completed on time.
Oversee timely development and distribution of audit reports and follow-up actions.
Identify potential systemic gaps and coordinate timely remediation with appropriate stakeholders.
Escalate critical noncompliance or insufficient urgency in remediation to senior management, as appropriate.
Oversee auditors contracted to provide auditing services for assigned programs.
Coordinate activities with other operational groups as required.
Assist with development and management of strategies for preparing for, hosting, and responding to regulatory agency inspections for GCP, GVP, GLP, and sponsor requirements.
Liaise with internal R&D functions and external groups, including contract auditors, clinical vendors, and investigator sites, to promote quality and consistency across studies.