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

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, 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

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%