Stability Program Lead, QA

Stability Program Lead, QA

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:

The Stability Program Lead is responsible for overseeing the management and coordination of stability testing programs conducted entirely by third-party contract organizations. This role ensures that all outsourced stability studies comply with GMP regulations and industry standards to support product quality and regulatory submissions. The Stability Program Lead supports system implementation, maintenance and operation, and acts as the primary liaison with external partners, driving program oversight, data integrity, and continuous improvement in stability processes.

Essential Job Duties and Functions:

• Develop, implement, and maintain the overall stability testing strategy and program, ensuring alignment with GMP guidelines and regulatory requirements (FDA, EMA, ICH, etc.) through all stages of clinical and commercial development.
• Supports the design and implementation of new stability data management systems to improve efficiency and data integrity.
• Manage relationships with third-party contract and storage facilities conducting stability studies, including vendor qualification, oversight, reviews, and performance monitoring.
• Implement a system for the collection, trending, analysis, and reporting of stability data received from third parties to ensure data integrity and compliance.
• Collaborate with internal departments and external partners to design, review, and approve stability study protocols, reports, requirements, and technical documents including evaluation of test parameters, time points, and storage conditions.
• Review of stability timepoints summaries and raw data.
• Coordinate timely communication and resolution of any deviations, out-of-specification results, or other issues arising during outsourced stability studies and manage associated quality records, as applicable.
• Evaluate stability data to assess performance, identify trends, and provide critical information for shelf-life determination.
• Ensure proper documentation control related to stability activities, including SOPs, contracts, protocols, reports, and change controls.
• Determine key process indicators (KPIs) metrics for stability programs and third-party oversight.
• 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:

• Education: Bachelor's degree or higher in a scientific discipline preferred.
• Experience: At least seven years of experience in Quality Assurance or Quality Control within the pharmaceutical industry, with a strong focus on quality systems, stability management experience, analytical laboratory experience. Expertise in chromatography (HPLC), data analysis software (e.g., Empower), and Laboratory Information Management Systems (LIMS) and/or data analysis software preferred. Three to five years focused on stability and/or stability management with experience in a quality analytical laboratory, and/or analytical instrument experience preferred.
• Analytical and scientific expertise to design complex studies and interpret data.
• Experience in quality or technical operations roles with expertise in the areas of small molecules, quality systems, GMP manufacturing, and stability preferred.
• Strong understanding of stability programs and analysis, including familiarity with electronic stability systems.
• In-depth knowledge of cGMP, FDA, foreign regulations (e.g., EU), and other international standards such as ICH and ISO.
• Ability to write procedures, develop protocols and reports, and communicate effectively across all levels of the organization.
• Proficiency in Microsoft Office; Veeva is a plus.
• Strong organizational, technical and writing skills
• Requires attention to detail, and the ability to manage multiple priorities independently.
• Excellent oral and written communication skills for effective interfacing with other departments within the company, suppliers, and other contractors.
• Working knowledge of pharmaceutical manufacturing and testing, the drug development process, validation, and regulatory guidelines and GMPs.
• Demonstrated ability to implement procedures which ensure compliance to GMP and regulatory standards.
• Generate and support GMP documentation, including SOPs, protocols, reports, etc.
• Develop and follow procedures for the oversight of quality aspects of stability in an outsourcing environment
• Demonstrated project management experience and skills, with the ability to coordinate numerous projects in a demanding, fast-paced environment.
• Ability to handle complex and challenging situations.

Salary range: $90,000 - $150,000, 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.