Associate Director, Research Quality Assurance

Akebia Therapeutics•Waltham, MA

8d•$159,939 - $197,571•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

Broad experience in product development, clinical operations, regulatory compliance and GCP, GVP, and/or 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.

Responsibilities

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