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SalaryAbout 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:
The Senior Manager/Associate Director, GCP Quality Assurance will work closely with the Clinical Trial Teams and Quality to manage and support a culture of quality, regulatory compliance, and continuous GCP inspection readiness. This position is responsible for all aspects of CQA activities to ensure Quality Assurance and compliance of Edgewise sponsored clinical trials with applicable GCP/GCLP/GVP regulations (e.g., FDA, EMA, ex-US, country-specific), ICH GCP guidelines, Edgewise Standard Operating Procedures (SOPs), and current industry standards and practices.
Essential Job Duties and Functions:
- Serve as the primary contact in QA for the quality oversight of Clinical Studies to ensure compliance with GCP/GCLP/GPV and all Regulatory requirements
- Plan, optimize, implement, manage, and continuously-improve phase appropriate
- GCP/GCLP/GPV Standard Operating Procedures (SOPs).
- Attend cross-functional study team meetings and provide professional expertise and guidance on GCP/GCLP/GPV and applicable regulations to clinical teams to proactively identify compliance issues/risks and recommend mitigation.
- Perform and follow-up on audits of Vendors, Laboratories, and Clinical Trial Sites in collaboration with QMS Management.
- Collaborate with Vendor Management and QMS Management to determine acceptability of vendors for potential use by Edgewise as well ongoing evaluation of overall compliance performance of vendors (CROs) and investigator sites.
- Ensure any Deviations, Quality Issues, and respective CAPAs are reported and managed appropriately.
- Escalate and manage the mitigation of critical audit findings, issues, and serious breaches as required per Standard Operating Procedures.
- Support QA Management with the preparation, coordination, and management of regulatory agency inspections.
- Assist with inspection preparedness of investigator sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory government agencies. Lead internal GCP inspection-readiness working groups, ensuring storyboards are created and risk areas are documented, mitigated, and escalated.
- Collaboratively work with other members of the QA department as needed to support the development of role-based training curricula and the distribution and monitoring of training compliance across the organization.
- Other tasks as assigned.
Required Education, Experience and Skills:
- Bachelor's degree, preferably in a scientific or technical discipline.
- Professional certifications related to Quality Assurance (e.g., RQAP-GCP, CQA) are a plus.
- A minimum of 10 years experience in the pharmaceutical or biopharmaceutical industry with clinical trial experience.
- Strong knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials.
- Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
- Expert knowledge of regulations, policies, and guidance in the US and internationally (GCP, GCLP, GPV, and ICH requirements, especially ICH E6R2) related to all phases of the Product Lifecycle (early stage clinical through commercial)
- Must possess excellent oral and written English communication skills.
- High integrity and ability to bring out the best in others, intellectually and interpersonally, on a cross-functional team.
- Ability to exercise judgment and address complex problems and find solutions across multiple projects.
- Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
- Business travel to be ~25% as required. Ability to travel domestically and internationally.
Salary range: $130,000-$180,000, 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.
