The Senior Director, Clinical Quality Assurance is responsible for establishing and implementing the strategy for the Clinical Quality Assurance (QA) function. This role is responsible for leading Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), and Good Pharmacovigilance Practice (GVP) QA activities including the development and execution of program or study level quality plans and proactively identify critical to quality risks and mitigation strategy to drive excellence in study execution and to minimize risk to regulatory submission/approval. The individual in this role partners with senior management and stakeholders to develop risk-based, phase-appropriate strategies focused on internal and external GCP, GVP, and GLP to ensure that clinical trials are conducted in compliance with applicable regulations, ICH guidelines, and industry best practices. This leader is skilled at building GLP, GCLP, and GVP QA processes and has in-depth knowledge of current industry best practices to support the evaluation of quality events. This individual is a subject matter expert to develop standards and partner with Preclinical, Clinical Development, including Translational Biomarkers, and Pharmacovigilance to ensure compliance with applicable regulations with regards to sponsor oversight of clinical programs. Where applicable, also partners with Information Technology for clinical computerized system validation projects.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary Responsibilities Include:

• Provide overall GCP/GVP/GLP leadership and strategic development for global GCP/GVP/GLP activities, its investigator sites and external service providers to ensure collaborative team involvement and implementation of quality and compliance initiatives
• Collaborate with Quality team and stakeholders to define and build the GLP/GCLP/GVP QA strategy and capability to support clinical portfolio while maintaining a strong independent role for QA decision making
• Develop appropriate procedures and documentation to ensure standards, practices and policies and procedures are in compliance with applicable laws and regulations
• Develop and implement global GCP/GVP/GLP Quality strategies for global Phase I - IV clinical studies, including establishment and maintenance of phase appropriate quality systems for drug, devices, and combination products; proactively identify and mitigate quality risks
• Work with cross functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and support KQI/KRI, detection, oversight, and trending with Clinical Development and Clinical Operations and other stakeholders
• Proactively identifying and communicating/escalating critical-to-quality risks and issues to management and supporting these risks and issues through action and resolution
• Proactively provide GxP QA support and guidance to Clinical Operations based on analysis and interpretation of GxP regulations to assure best clinical QA practices
• Able to adapt precedent and develop creative and effective solutions to solve problems
• Lead Quality Event investigations, root cause analysis, and relevant CAPA.
• Develop and deliver training to the research and development organizations to develop a working knowledge of regulations (e.g., GLP, GCP, CFR Part 11)
• Lead domestic and international audits of sites, documents, databases, vendors, or internal systems in collaboration with other Quality team members
• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks as needed
• Support investigational new drug applications and related correspondence from global regulatory authorities
• Develop and oversee appropriate Quality metrics and reporting on the state of compliance to senior management regarding critical quality and compliance related issues and corrective actions to mitigate risk
• Assure global regulations are followed for clinical trial reporting, including submission of adverse events/SAE reporting and all required clinical reports
• Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes
• Review regulatory and corporate compliance risks, alerting senior management when needed
• Serve as a resource to global clinical and safety personnel on compliance issues, preparations for external inspections, regulatory risk, and process improvement opportunities
• Oversee GCP/GVP/GLP Quality incident investigations, including input and approval of plans for resolution of Quality issues, partnering with internal and external stakeholders to ensure CAPAs are appropriate and effective
• Develop and implement risk-based Study Audit Plans and support development of Quality Risk Management Plans
• In collaboration with functional area leaders, ensure clinical and pharmacovigilance service providers comply with the applicable quality program and regulations/guidelines, and are prepared for Regulatory inspections
• Proactively provide consultative GCP/GVP/GLP QA support to global clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency

Education and Skills Requirements:

• Bachelor's degree in a scientific discipline is required
• Minimum of 10 years of experience in clinical research area inclusive of, but not limited to, GLP, GCP, GVP QA and compliance
• GCP QA professional with broad drug experience that spans all clinical phases (Phase I to BLA/NDA)
• Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations
• Strong understanding of GCP Quality for pre-clinical, clinical, and commercial stage work and in-depth experience implementing and ensuring GCP requirements in clinical trials (e.g., GCP oversight, auditing, global inspection readiness.)
• Proven experience in successfully developing and implementing a risk-based clinical quality assurance program
• Experience leading/hosting global regulatory authority inspections and developing responses to regulatory authority inspection findings
• Proven track record of demonstrating good judgement & decision-making experience
• Excellent organizational skills
• Ability to concisely present quality events and the criticality to internal stakeholders
• Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues
• Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, quality events, investigations, training, and CAPA
• Working knowledge of the therapeutic area would be beneficial
• Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources, consistently delivers
• Flexible and creative problem-solving skills; ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

PRECISION LIFE SCIENCES

Posted On: Tuesday, May 30, 2023