Manager, GMP Quality Assurance (EDG-2026035)

Manager, GMP Quality Assurance (EDG-2026035) Boulder, CO 80303 $110 - $150 an hour $110 - $150 an hour

Manager, GMP 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:

The GMP Quality Assurance Manager supports the compliant manufacture, testing, and distribution of clinical‑stage and any future commercial pharmaceutical products in accordance with applicable cGMP regulations. This role is part of a dynamic, highly experienced Quality Assurance organization and is responsible for hands‑on execution of document‑centric and coordination‑intensive GMP quality activities under the direction of senior QA leadership. The position partners closely with Contract Manufacturing Organizations (CMOs) and internal stakeholders including CMC/Technical Operations, Analytical Development, Supply Chain, and Regulatory Affairs to ensure safe and effective products for our patients; inspection‑ready quality systems, robust GMP documentation, and timely, risk‑based quality decision‑making. This is an execution‑focused manager role designed for professionals who excel in structured, detail‑oriented environments and who drive quality processes to closure.

Essential Job Duties and Functions:

Perform first‑pass Quality Assurance review of GMP documentation (e.g., SOPs, protocols, reports, executed batch records, and supporting records) to assess accuracy, completeness, consistency, and alignment with internal quality standards and applicable cGMP regulations. Conduct GMP batch record review for clinical and commercial materials, identifying discrepancies, required follow‑ups, and documentation gaps. Support the day‑to‑day operation and maintenance of the Quality Management System (QMS), including deviations, investigations, change controls, and document lifecycle management. Maintain quality records and workflows in Veeva QMS and support quality metrics tracking and reporting. Support document control activities, including document routing, version control, comment consolidation, issuance, archival, and retirement within approved electronic document management systems. Assist with the authoring, revision, and maintenance of GMP SOPs, work instructions, templates, and job aides under the guidance of senior QA staff. Ensure documentation meets both data integrity and Good Documentation Practice (GDP) requirements and supports regulatory inspection readiness. Perform initial QA triage of deviations, investigations, and change controls originating from CMOs or internal stakeholders. Draft preliminary QA assessments and recommendations for senior QA review to support timely, risk‑appropriate quality decisions. Track quality records and associated action items through to closure, ensuring appropriate documentation and follow‑up. Support quality oversight of CMOs, including tracking Quality Agreement commitments, deliverables, and due dates. Prepare QA meeting materials, data packets, agendas, and meeting minutes for CMO quality forums. Support follow‑up, escalation, and documentation of CMO quality topics and commitments. Support the development and maintenance of GMP training materials, onboarding content, and role‑based training documentation. Comply with all company policies, workplace health and safety requirements, and standard operating procedures. Perform other quality‑related duties as assigned.

Required Education, Experience and Skills:

Bachelor's degree in life sciences, chemistry, engineering, or a related discipline (or equivalent GMP experience). 5+ years of GMP Quality Assurance experience in pharmaceutical or biotechnology environments. Demonstrated hands‑on experience with GMP documentation review, root cause analysis (RCA), batch records, deviations, investigations, change controls, and SOP management. Working knowledge of cGMP regulations (FDA and ICH required; EMA experience preferred). Experience supporting or overseeing external CMOs preferred. Proficiency with electronic QMS and document management systems (Veeva preferred). Strong written and verbal communication skills, with the ability to distill complex quality topics into clear, concise summaries. Highly organized, detail‑oriented, and able to manage multiple priorities in a fast‑paced, regulated environment.

Salary range:

$110,000 - $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.