Manager/Senior Manager, GxP Quality Systems (EDG-2025076)

Edgewise Therapeutics • Boulder, CO

22d • $90,000 - $140,000

About The Position

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 Manager/Sr. Manager, GxP Quality Systems will be responsible for a wide variety of activities to ensure compliance with applicable regulatory requirements, company policies and procedures. This will include overseeing quality systems, leading management review boards, developing and performing training, authoring documents and tracking/reporting metrics.

Requirements

• Bachelor's degree in a scientific discipline preferred
• 5+ years pharmaceutical/biotechnology experience in Quality Assurance/Systems, supporting GxP (GLP, GCP, GMP).
• Strong understanding of electronic quality management systems (Veeva preferred) as well as literacy in Microsoft Word, Access, Excel, and others as required.
• Knowledge of FDA regulations and ICH Guidelines and experience with international regulations and guidelines.
• Knowledge of Quality principles, concepts, systems, industry practices, and standards in relation to document management, training, change control, deviations and corrective/preventive actions.
• Ability to author and review multiple types of documents, with strong attention to detail.
• Ability to clearly communicate (verbally & in writing) and work well with employees at all levels in a collaborative manner.
• Must possess excellent verbal and written communication skills along with sound organization skills applicable to quality systems management.
• Ability to meet multiple deadlines across a variety of projects with a high degree of accuracy and efficiency.
• Independent, organized, and able to manage workload with minimal supervision to meet schedule deadlines.

Responsibilities

• Develop and administer the activities of the quality management boards, including the Change Control Board, and other Quality Management Review (QMR) meetings.
• Create agendas, compose meeting minutes, and record attendance for assigned Quality board meetings.
• Present metrics at the Quality board meetings and assist with development and improvement of the board's efficiencies.
• Serve as the subject matter expert on the electronic quality systems (Veeva) and maintain a thorough understanding of system capabilities to provide support to record owners.
• Assist in and prepare for the execution of foreign and domestic regulatory agency inspections and mock audits by assisting with requests that are generated from the audit.
• Lead the training management program by designing and maintaining curriculums across multiple departments.
• Perform company-wide cGMP and Electronic QMS training on an as-needed basis.
• Develop and report metrics to support QMR and KPls for the boards and the progress of records through the system.
• 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.
• Perform other duties as assigned

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees