What are the responsibilities and job description for the Senior Manager, Clinical Quality Assurance position at Edgewise Therapeutics?
Senior Manager, Clinical 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 preclinical 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 and make a significant difference in the lives of patients!
About the Position :
The Senior Manager, CQA will be responsible for driving Clinical Quality Assurance (CQA) activities in support of clinical development projects across multiple therapeutic areas. Provides CQA expertise, direction, and training to ensure adherence with applicable regulatory requirements and company policies and procedures.
Essential Job Duties and Functions :
- Work with a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training.
- Lead, plan, conduct, and oversee GCP audits (e.g. vendors, clinical investigator site, internal audits) to ensure compliance with applicable GCP / regulatory requirements and guidelines, study protocols, study plans, and applicable policies / procedures.
- Assist in the development and execution of audit plans for assigned programs in line with the overall CQA annual audit strategy, including performing audits, collaborating with contract auditors, and communicating audit outcomes to internal and external stakeholders as applicable.
- Develop, report, and assess GCP metrics; conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP CQA activities) for management reporting.
- Proactively identify areas for improvement and collaborate cross-functionally on continuous improvement initiatives.
- Apply a risk-based approach to decision-making, guidance, and issue mitigation.
- Support issue management and corrective / preventive action management activities across the organization and with external service providers.
- Assist in the preparation for global regulatory agency inspections and mock inspections.
- Participate in GCP inspections by regulatory agencies. Manage proactive GCP inspection readiness activities globally. Support questions from regulators, review boards, ethics committees, development partners, etc.
- Other duties as assigned.
Required Education, Experience, and Skills :
Salary range : $115,000-$155,000, title and salary commensurate with experience
Our Benefits : We are proud to offer health benefits, a discretionary bonus plan, and 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.
Salary : $115,000 - $155,000