Senior Director/Executive Director, Clinical Quality Assurance (EDG-2025052)
3 Days Old
About Edgewise Therapeutics:
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
Position Summary:
Edgewise Therapeutics is seeking an accomplished and strategic leader to serve as Senior Director or Executive Director, Clinical Quality Assurance (CQA) (level to be determined based on experience). This role is responsible for the global CQA strategy and operations across all clinical development programs, with a demonstrated ability to build and sustain a culture of quality and operational excellence.
Reporting to the Vice President of Quality, the individual will oversee the clinical quality team and provide enterprise-level CQA leadership across all Clinical Development functions-including Clinical Operations, Pharmacovigilance (PV), Biostatistics, Data Management, and Medical Affairs. The successful candidate will ensure end-to-end quality oversight and inspection readiness across all GCP- and GVP-relevant activities.
This role requires a forward-thinking, diplomatic, and detail-oriented quality professional with an advanced understanding of global regulatory requirements governing clinical research and safety, and practical application of Quality Risk Management (QRM) principles. The candidate will serve as the primary QA contact for clinical and PV regulatory inspections, lead vendor quality oversight, and collaborate cross-functionally to ensure regulatory compliance, continuous improvement, and proactive risk mitigation across all clinical quality functions.
This position combines strategic leadership with hands-on operational quality management, audit oversight, and inspection readiness, supporting Edgewise's mission to deliver safe, effective therapies to patients.
Key Responsibilities:
Strategic Leadership & Oversight:
- Provide strategic and operational leadership for Clinical Quality Assurance (CQA) 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 all Clinical Development functions - including Regulatory Affairs, Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, and Medical Affairs - to proactively identify, assess, and mitigate quality and compliance risks across the development lifecycle.
Quality Management System (QMS):
- Own and continuously improve the Clinical QMS, including Policy & SOP lifecycle management, risk assessment, and inspection readiness tools.
- Define and report on KPIs/metrics to measure quality performance and drive continuous improvement.
- Develop and maintain 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 (e.g., protocols, ICFs, safety plans) for regulatory compliance and quality alignment.
Vendor and Clinical Site Oversight:
- Lead a robust, risk-based audit program - planning and executing qualification, routine, and for-cause audits - across clinical investigator sites, CROs, eTMF systems, clinical study reports, pharmacovigilance service providers, and central laboratories; ensure timely CAPA development and implementation.
- Oversee vendor qualification and routine audit activities, ensuring timely and effective CAPA implementation.
- Perform audits as necessary, up to ~20% of time.
Inspection Readiness:
- Act as primary CQA contact for global regulatory agency inspections (FDA, EMA, MHRA, PMDA, etc.).
- Lead inspection readiness strategy, and mock inspections, including inspection preparation and follow-up, and efficiently track CAPAs and follow-up commitments.
- Conduct periodic reviews of critical clinical trial documentation and inspection-related repositories to ensure completeness and compliance.
Regulatory Intelligence and Policy Development:
- Maintain awareness of global GCP/GVP/GLP developments and ensure internal processes remain current with evolving requirements.
- Partner with Regulatory, Clinical Operations, Pharmacovigilance, and other departments to embed quality throughout the development lifecycle.
Training and Communication:
- Collaborate with QMS and functional leaders to deliver targeted training on inspection readiness, deviation/CAPA management, and quality risk assessment practices.
- Represent QA in cross-functional governance meetings, development teams, and external engagements.
General:
- Define and manage CQA budget.
- Capable of managing multiple priorities independently in a fast-paced environment while ensuring timely and organized deliverables.
- Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and 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.
- Demonstrated 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.
- Certification in Quality/Auditing (e.g., RQAP-GCP, ASQ, or equivalent) preferred.
- Line management and mentoring staff
Salary range: $225,000 - $275,000, title and salary commensurate with experience
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer 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.
- Location:
- Boulder