Director, Clinical Quality Assurance

Role Summary:

The Director of Clinical Quality Assurance is responsible for leading Good Clinical Practice (GCP) Quality Assurance (QA) and serves as the GCP Quality representative for clinical study teams. This leader is skilled at building GCP processes and has in-depth knowledge of current GCP practices. This individual is the subject matter expert in GCP, is responsible for developing standards and partnering with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Affairs, and other functions to establish and document risk based GCP processes and procedures. This role ensures compliance with applicable regulations with regards to sponsor oversight of Dyne's clinical programs. This role is responsible for continuing to build out the quality infrastructure and evaluate, identify, and reduce compliance risk by contributing to the development and maintenance of efficient and effective Clinical Quality procedures to achieve the highest level of data quality and integrity.

This is a full-time position based in Waltham, MA without the possibility of being remote and requires ~25% travel.

Primary Responsibilities Include:

• Provide leadership and operational management for all Dyne Clinical Quality Assurance (CQA) activities to provide assurance of subject protection and data integrity under GCP regulations including Clinical QA audit program development and management, Clinical Quality issue management, Clinical QA SOP development and maintenance, General GCP training, GCP Regulatory inspection preparation and management, Keep leadership apprised of changes to the Clinical Quality compliance landscape affecting business performance
• Prepare and implement risk-based audit plans for clinical studies. Coordinate/perform and/or support GCP auditing activities and observation resolution to ensure that studies are conducted in accordance with the study protocols, regulations and GCP
• Collaborate with Clinical Operations, clinical sites and CROs to provide ongoing quality support and oversight during the set-up, conduct and completion of clinical studies to ensure participant safety and data integrity
• Lead the GCP inspection readiness/inspection support activities at the CROs and clinical sites
• Perform CQA reviews of clinical study protocols, Brochures, Patient Information Sheets / Informed Consent and Assent forms, and other related clinical study documents as needed
• Develop, establish, and implement GCP Clinical Quality Assurance (CQA) oversight and management processes and procedures
• Write, review and approve SOPs associated with Clinical Operations and Development
• Support the Quality group's oversight efforts with quality systems such as change control, quality investigations, CAPA identification and resolution, audits, and any other recommendations to compliance issues and/or observations as they arise
• Report and escalate significant quality observations/risks to leadership
• Facilitate and/or conduct internal Clinical Quality training for employees and contractors
• Lead resolution of CGP compliance issues
• Assess adequacy of GCP activities by planning and overseeing the execution of a comprehensive GCP Quality Assurance audit program
• Ensure US CQA audits are aligned with organization's local and global procedures
• Ensure efficiency in CQA processes that support and drive continuous quality improvement
• Facilitate GCP quality issue management and assesses adequacy of proposed corrective and preventive actions (CAPA)
• Provide GCP compliance advice and support to Clinical Development
• Identify and communicate to senior management the trends impacting Clinical Quality
• Recommend changes to policies and procedures that improve quality and efficiency
• Embrace latest technology to enhance visualizations of Quality Assurance metrics that facilitate better decision-making
• Facilitate continuous learning and knowledge transfer with team members
• Serve as the point of contact in managing GCP audit collaboration with vendors and sites
• Provide support and advice to organizations in preparing for and through participation in GCP inspections

Educational and Skills Requirements

• Bachelor's degree or higher in a relevant field such as life sciences, nursing, pharmacy, or public health
• 10+ years of relevant experience in pharmaceutical or biotechnology
• 8+ years Good Clinical Practice and Quality Management System experience
• Experience in development and implementation of Clinical Quality Management Systems for GCP
• Excellent Microsoft Office (Word, Excel, Smartsheet, PowerPoint, Outlook) skills
• Familiarity with common applications used in management of GCP Quality Management activities
• Strong analytical skills and problem-solving capabilities
• Advanced communication and interpersonal skills (e.g., conflict resolution, teamwork, impact and influence, communication, etc.)
• Ability to create and deliver informative and persuasive presentations to internal team members, external parties, and organization's executive leaders
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is proactive and willing to jump in to support Dyne QA activities
• Excellent organizational skills with the ability to prioritize, work with minimal supervision, proactively identify areas for improvement, and drive initiatives from identification to completion independently
• Ability to develop and apply creative solutions to complex issues, and adapt to changing needs and situations

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