Quality Assurance Specialist

The Quality Assurance Specialist will contribute to the success of OnKure through partnering with internal functional teams to effectively provide QA support for quality operations and administer a phase appropriate Quality Management System that is fit for purpose, maximizes efficiency, complies with biotech industry standards, and achieves desired compliance with regulatory, clinical, and business operations goals. This full-time position reports to the Director, Quality Assurance. 

Job Responsibilities:

• Perform batch record review, approval and batch release in support of clinical trials.


• Evaluate compliance of completed manufacturing records (batch records, COC/ COA, and any related data as applicable) from CMO as necessary to ensure that they are accurate and complete


•  Review all the supporting documents regarding Quality System documentation including deviations, OOS, product complaints, CAPAs, and document /change controls-related processes, both internally and for GxP vendors


• Provide Quality Assurance support for the OnKure stability programs, including review and approval of stability protocols and reports. 


• Provide Quality Assurance support in the drafting and periodic review of controlled documentation, including SOPs, WIs, and Corporate Policies


• Works within and acts as the administrator of the electronic document management system (eDMS)


• Provide and execute innovative ideas to advance document process efficiencies and share best practices


• Own the GxP training program. Maintain training records and assignments in the learning management system. 


• Support vendor qualification and oversight


• Contribute to the development and implementation of additional phase appropriate Quality Systems processes. 


• Partner with Clinical Operations, Regulatory, CMC and Nonclinical teams


• Promote a culture of quality and continuous improvement


• Other job duties associated as required

Preferred Experience and Qualifications:

• Bachelor’s degree in a related field, or equivalent experience


• Minimum 5 years working in a quality assurance role 


• Experience using electronic Document Management and Learning Management/Training Systems, administrator experience preferred


• Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.


• Ability to perform a variety of duties, often changing from one task to another.


• Proficiency with Microsoft Outlook tools (Excel, Word, Vision, Project, SharePoint, Teams, and PowerPoint

About OnKure:

We are a clinical-stage biopharmaceutical company focused on discovering and developing precision medicines that target biologically validated drivers of diseases underserved by available therapies. Using a structure- and computational chemistry-driven drug design platform, we are committed to improving clinical outcomes for patients by building a robust pipeline of small-molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer and vascular anomalies.

To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability) for full-time employees, self-managed paid time off, and a 401(k) plan with company match. Candidates who live in or are willing to relocate to the Boulder, CO area are preferred.

The annual compensation range for this role, based on experience, is $105,000-$125,000.

OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, protected veteran status, disability, or any other protected factors.