Director, GLP/GCP Quality Assurance

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!

About the Position:

Edgewise Therapeutics is seeking an experienced, collaborative, and dynamic Director of nonclinical and Clinical Quality Assurance. The successful candidate will be responsible for improving and maintaining a robust Quality Management System (QMS) that ensures compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations. This role will support development activities across multiple programs and ensure regulatory and corporate standards are met.

Essential Job Duties and Functions:

Quality Management System (QMS):

• Foster a strong quality culture by leading the execution and continuous improvement of the QMS.
• Develop, review, and update Policies and Standard Operating Procedures (SOPs) to ensure compliance with evolving regulatory requirements.
• Establish metrics/key performance indicators and report on the QMS effectiveness in stakeholder forums.
• Analyze data trends and implement corrective and preventive actions to drive continuous quality improvement.
• Provide guidance on compliance issues and support clinical teams.
  
  
  

Audit Program:

• Manage and execute a risk-based audit program for internal and third-party operations, e.g., clinical sites and CROs.
• Coordinate and communicate audits (agendas, findings, and responses) with internal stakeholders.
• Conduct qualification and monitoring audits of investigator sites and CROs to ensure compliance with corporate and regulatory standards.
• Ensure clinical trials comply with GCPs and corporate policies and procedures.
  
  
  

Inspection Readiness:

• Define and implement global health authority inspection readiness plans.
• Coordinate health authority and mock inspections of internal operations, clinical sites and CROs.
• Coordinate timely preparation of responses to health authority findings and ensure commitments are met.
  
  
  

Training and Development:

• Review and approve curricula and ensure assignment completions are current.
• Provide training to staff on current GCPs and inspection management.
  
  
  

Regulatory Intelligence:

• Ensure compliance with new and emerging regulations prior to effective dates
• Remain current on the GCP/GLP compliance landscapes via conferences and personal networking.
  
  
  

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:

• B.S. in scientifically related field
• 10+ years of clinical quality assurance experience, including experience with BIMO inspections, international GCP/GLP regulations and multi-national clinical trials.
• Certified GCP auditor
• Extensive knowledge of GCP regulations and SOP implementation; experience in GVP and GLP compliance is a plus.
• Excellent analytical and problem-solving skills, with the proven ability to think strategically.
• Highly effective team and interpersonal skills with the ability to work across numerous scientific disciplines.
• Excellent diplomatic, analytical, organizational and communication skills, both verbal and written
• Eager to be part of an organization discovering and developing drugs for patients with severe illnesses to live longer, better lives.
  
  
  

Up to 25% travel.

Salary range: $170,000-$220,000, 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.