Edgewise Therapeutics
Senior Director/Executive Director, Clinical Quality Assurance (EDG-2025052)
Edgewise Therapeutics, Boulder, Colorado, United States, 80301
Overview
Edgewise Therapeutics is seeking a Senior Director or Executive Director, Clinical Quality Assurance (CQA) to lead the global CQA strategy and operations across all clinical development programs. The role focuses on building and sustaining a culture of quality and operational excellence, ensuring end-to-end quality oversight and inspection readiness across GCP- and GVP-relevant activities. Reporting to the Vice President of Quality, the incumbent will oversee the clinical quality team and provide enterprise-level CQA leadership across Clinical Development functions including Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, and Medical Affairs. Key Responsibilities
Provide strategic and operational leadership for Clinical Quality Assurance across all clinical programs and studies. Lead and grow the CQA function, including mentoring, hiring, and developing internal staff and managing external consultants in a matrixed, cross-functional environment supporting global clinical trials. Effectively manage competing priorities and drive high-quality deliverables in a dynamic, fast-paced environment. Define and implement a comprehensive CQA strategy that aligns with program milestones, regulatory expectations, risk management principles, and stakeholder objectives to safeguard patient safety and data integrity. Collaborate cross-functionally with Regulatory Affairs, Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, and Medical Affairs to identify, assess, and mitigate quality and compliance risks across the development lifecycle. Quality Management System (QMS) & Quality Assurance Activities
Own and continuously improve the Clinical QMS, including policy and SOP lifecycle management, risk assessment, and inspection readiness tools. Define and report KPIs/metrics to measure quality performance and drive continuous improvement. Develop methodologies and tools for proactive risk identification and management across clinical trials. Provide guidance on compliance issues and support clinical teams. Represent QA on clinical study teams, ensuring review and approval of essential documents for regulatory compliance and quality alignment. Vendor and Site Oversight; Inspection Readiness
Lead a robust, risk-based audit program across clinical investigator sites, CROs, eTMF systems, study reports, pharmacovigilance service providers, and central laboratories; ensure timely CAPA development and implementation. Oversee vendor qualification and routine audit activities, ensuring timely CAPA implementation. Perform audits as necessary (up to ~20% of time). Act as primary CQA contact for global regulatory inspections and lead inspection readiness strategies, mock inspections, and CAPA follow-up. Regulatory Intelligence, Training & Communication
Maintain awareness of global GCP/GVP/GLP developments and ensure internal processes stay current with evolving requirements. Partner with Regulatory, Clinical Operations, Pharmacovigilance, and other departments to embed quality throughout the development lifecycle. Collaborate to deliver targeted training on inspection readiness, deviation/CAPA management, and quality risk assessment; represent QA in governance and cross-functional meetings. General
Define and manage the CQA budget. Manage multiple priorities independently in a fast-paced environment while ensuring timely, organized deliverables. Comply with workplace health and safety policies and company procedures. Perform other duties as assigned by supervisor. Required Education, Experience, and Skills
Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred. 15+ years of progressive experience in clinical quality assurance in the pharmaceutical or biotech industry, including at least 5 years in a senior leadership capacity. Proven success in leading GCP and GVP programs through clinical phases and health authority inspections; GLP experience desired. Deep understanding of global regulatory frameworks (FDA, EMA, ICH E6, MHRA, PMDA, etc.). Proven ability to manage audits, inspection readiness, CAPA programs, and QMS infrastructure. Strong interpersonal and cross-functional leadership skills, including vendor and consultant oversight. Quality/Auditing certification (e.g., RQAP-GCP, ASQ, or equivalent) preferred. Line management and mentoring experience. Compensation & Benefits
Salary range: $225,000 - $275,000, with title and salary commensurate with experience. Benefits include health benefits, a discretionary bonus plan, stock option grants, stock purchase plan, and a 401(k) with match, plus paid time off. Additional Information
There is no deadline for applications; Edgewise accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
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Edgewise Therapeutics is seeking a Senior Director or Executive Director, Clinical Quality Assurance (CQA) to lead the global CQA strategy and operations across all clinical development programs. The role focuses on building and sustaining a culture of quality and operational excellence, ensuring end-to-end quality oversight and inspection readiness across GCP- and GVP-relevant activities. Reporting to the Vice President of Quality, the incumbent will oversee the clinical quality team and provide enterprise-level CQA leadership across Clinical Development functions including Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, and Medical Affairs. Key Responsibilities
Provide strategic and operational leadership for Clinical Quality Assurance across all clinical programs and studies. Lead and grow the CQA function, including mentoring, hiring, and developing internal staff and managing external consultants in a matrixed, cross-functional environment supporting global clinical trials. Effectively manage competing priorities and drive high-quality deliverables in a dynamic, fast-paced environment. Define and implement a comprehensive CQA strategy that aligns with program milestones, regulatory expectations, risk management principles, and stakeholder objectives to safeguard patient safety and data integrity. Collaborate cross-functionally with Regulatory Affairs, Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, and Medical Affairs to identify, assess, and mitigate quality and compliance risks across the development lifecycle. Quality Management System (QMS) & Quality Assurance Activities
Own and continuously improve the Clinical QMS, including policy and SOP lifecycle management, risk assessment, and inspection readiness tools. Define and report KPIs/metrics to measure quality performance and drive continuous improvement. Develop methodologies and tools for proactive risk identification and management across clinical trials. Provide guidance on compliance issues and support clinical teams. Represent QA on clinical study teams, ensuring review and approval of essential documents for regulatory compliance and quality alignment. Vendor and Site Oversight; Inspection Readiness
Lead a robust, risk-based audit program across clinical investigator sites, CROs, eTMF systems, study reports, pharmacovigilance service providers, and central laboratories; ensure timely CAPA development and implementation. Oversee vendor qualification and routine audit activities, ensuring timely CAPA implementation. Perform audits as necessary (up to ~20% of time). Act as primary CQA contact for global regulatory inspections and lead inspection readiness strategies, mock inspections, and CAPA follow-up. Regulatory Intelligence, Training & Communication
Maintain awareness of global GCP/GVP/GLP developments and ensure internal processes stay current with evolving requirements. Partner with Regulatory, Clinical Operations, Pharmacovigilance, and other departments to embed quality throughout the development lifecycle. Collaborate to deliver targeted training on inspection readiness, deviation/CAPA management, and quality risk assessment; represent QA in governance and cross-functional meetings. General
Define and manage the CQA budget. Manage multiple priorities independently in a fast-paced environment while ensuring timely, organized deliverables. Comply with workplace health and safety policies and company procedures. Perform other duties as assigned by supervisor. Required Education, Experience, and Skills
Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred. 15+ years of progressive experience in clinical quality assurance in the pharmaceutical or biotech industry, including at least 5 years in a senior leadership capacity. Proven success in leading GCP and GVP programs through clinical phases and health authority inspections; GLP experience desired. Deep understanding of global regulatory frameworks (FDA, EMA, ICH E6, MHRA, PMDA, etc.). Proven ability to manage audits, inspection readiness, CAPA programs, and QMS infrastructure. Strong interpersonal and cross-functional leadership skills, including vendor and consultant oversight. Quality/Auditing certification (e.g., RQAP-GCP, ASQ, or equivalent) preferred. Line management and mentoring experience. Compensation & Benefits
Salary range: $225,000 - $275,000, with title and salary commensurate with experience. Benefits include health benefits, a discretionary bonus plan, stock option grants, stock purchase plan, and a 401(k) with match, plus paid time off. Additional Information
There is no deadline for applications; Edgewise accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
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