Quality Systems Associate

Summary

Description Position Summary:

The Quality Systems Associate contributes to the success of OnKure through partnering with internal functional teams to effectively 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 Associate Director, Quality Assurance.

Essential Duties And Responsibilities

• Provide Quality Assurance support in the drafting and periodic review of controlled documentation, including SOPs, WIs, and Corporate Policies
• Work within an electronic document management system (eDMS)
• Reconcile and drive closure of document changes, formatting of controlled documents, and maintaining legacy controlled documents
• Manage and lead legacy document migrations into electronic document management system
• Provide and execute innovative ideas to advance document process efficiencies and share best practices
• Partner with HR and department managers to create new hire training assignments
• Maintain training records and assignments in the learning management system
• Create periodic reports for Training and Document Control to track, trend and follow up with personnel as needed
• Contribute to the development and implementation of additional phase appropriate Quality Systems processes
• Other job duties associated with Quality Management Systems as required
  
  

Qualifications

• Bachelor’s degree in a related field, or equivalent experience
• Minimum 1 year working in a quality assurance role
• Experience using electronic Document Management and Learning Management/Training Systems 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 Office tools (Outlook, Excel, Word, Vision, Project, SharePoint, Teams, and PowerPoint)
  
  

About OnKure

OnKure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure- and computational chemistry-driven drug design platform, OnKure is 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.

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 expected annual compensation range for this role, based on experience, is $80,000-$100,000.

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.