Deputy Director, Clinical Quality Management, Center for Vaccine Innovation and Access

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PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing heath challenges. 

PATH’s Center for Vaccine Innovation and Access (CVIA) brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA’s current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against fifteen different diseases. Our focus is on vaccines to address the leading diseases that claim children’s lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others. PATH has led numerous global partnerships, including the award-winning Meningitis Vaccine Project and the Malaria Vaccine Initiative, which helped develop the first malaria vaccine candidate recommended for pilot implementation.

PATH is currently seeking a highly skilled and experienced individual to join the team in the crucial role of Deputy Director, Clinical Quality Management. This position will report to the Global Head, Quality Unit, CVIA. The Deputy Director will play a pivotal role in ensuring the integrity, compliance, and quality of PATH clinical studies globally. This senior-level position requires an individual with extensive industry experience, exceptional leadership skills, and a proven track record in developing and implementing fit for purpose quality management systems for clinical practices.

Responsibilities

• Pioneer industry-leading clinical quality assurance techniques and approaches while maintaining compliance and efficiency in related operational processes. Develop strategies to identify and mitigate related risks across good clinical practices (GCP) activities.
• Provide strategic leadership and direction for the Clinical Quality Assurance operations.
• Develop, implement, and continuously improve global GCP quality strategies that align with PATH’s goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.
• Evolve and chair the Clinical Quality Functional Area review to ensure the review meets its intended purpose and remains current with external and internal requirements, including seamless integration with Clinical Operations and CVIA Leadership Team Management review.
• Assess gaps, develop, and implement robust quality management systems for clinical practices, ensuring adherence to regulatory standards and best practices.
• Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
• Relentlessly explore leading edge, innovative principles and practices associated with progressive quality management; takes bold steps to incorporate into Company Quality strategy, Quality Management systems, practices; continuously drive meaningful change.
• Drive recommendations and manage tasks to closure, providing guidance and support to resolve issues identified during audits and inspections.
• Provide interpretation and guidance on GCP related regulations/ guidelines (FDA, ICH, EU, etc.), including Risk Based Quality Management, and company procedures and policies.
• Collaborate with PATH partners, including Principal Investigator (PI) and Contract Research Organizations (CROs), to ensure alignment on quality expectations and timely resolution of issues.
• Coordinate with cross-functional teams (e.g., Program Leads, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance) to develop and implement phase-appropriate procedures ensuring consistency and quality with respect to clinical trial support activities.
• Manage international inspections, ensure readiness and compliance of clinical sites, and provide feedback and recommendations for improvement.
• Report GCP related deficiencies and associated risks to management as well as plans for risk mitigation and corrective and/or