Job Description
Description Description
Position Description: This position in Quality Assurance provides strategic and technical support of the Quality Management System (QMS) and is responsible for ensuring GxP and QMS compliance. This position is responsible for ensuring Quality Programs are developed, implemented, and effectively administered in a manner that is fit for purpose, maximizes efficiency, complies with development-stage biotech industry standards, and achieves desired compliance with regulatory, clinical, and business operations goals. The ideal Quality Assurance candidate will have small-molecule, development-phase GMP experience, and also have a strong desire and proven ability to implement quality initiatives across GxP functions. The candidate should have previous experience managing and mentoring others in Quality Assurance and be passionate about instilling a practical, efficient, and risk-based quality approach within the Quality Assurance group and throughout the company.
Essential Duties And Responsibilities - Lead and manage the OnKure Quality Assurance team
- Own the OnKure QMS and oversee the implementation of fit-for-purpose quality initiatives, processes, tools and trackers
- Partner with other members of the Quality Assurance team to provide enhancements to Quality Systems to improve efficiency, regulatory compliance, and reduce manual processes
- Author and manage to resolution quality events including deviations, CAPAs, investigations, and change controls
- Perform or oversee GxP and vendor audits
- Implement and perform periodic quality management reviews, develop phase-appropriate Quality metrics/KPIs
- Continually assess compliance status of clinical and CMC development programs
- Perform quality review and approval of IMP manufacturing documentation and provides disposition of drug substance, drug product and clinical trial material
- Liaise between external QP and internal teams to ensure prompt IMP distribution
- Manage supplier activities, including support of supplier qualification assessments and verification of approval requirements, approved supplier listing and supplier file maintenance, and any ongoing monitoring of supplier relationships and deliverable expectations
- Business system owner for the electronic QMS and support the Quality Systems Associate with:
- Drafting and periodic review of controlled documentation, including SOPs, WIs, and Corporate Policies
- Document archiving
- Partnering with cross functional teams to evaluate training assignments, develop and maintain training matrices, and drive training completion timelines
- This position requires the incumbent to perform daily hands-on Quality administrative activities as required.
Preferred Experience and Qualifications: - Bachelor’s degree or equivalent
- 10+ years (Director) of quality experience, in pharmaceutical industry; including experience in development phase GMP QA
- Strong knowledge of GxP regulations, Quality Systems (including Document Control, Training, Change Control, computer system validation, 21 CFR Part 11) and relevant regulatory guidance documents
- Strong leadership skills with ability to provide strategic input into quality programs as well as contributing to tactical and administrative tasks
- Excellent interpersonal skills and regarded as trustworthy and collaborative by peers
- Ability to work with cross functional teams to assess complex issues and to recommend pragmatic, relevant, and realistic solutions, and when appropriate leading implementation of solutions
- Proficiency and experience with electronic Quality Management Systems including management and maintenance
- Experience with FDA and/or other regulatory agency inspections and inspection readiness activities
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 $200,000-225,000.
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.
Job Tags
Full time, Relocation,