Associate Director, Quality Assurance
- Job Title
- Associate Director, Quality Assurance
- Job ID
- Boulder, CO
- Other Location
The Senior Manager or Associate Director, Quality Assurance is responsible for the Quality Management System, including control of GxP documentation and SOP development, maintenance, and training, as well as management of quality and technical agreements, qualification of suppliers and coordination/management of supplier audits. This position has ownership of GxP compliance and Document Control programs including program strategy, planning, and organizing projects. 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 biotech industry standards, and achieves desired compliance with regulatory, clinical, and business operations goals. A candidate with a background in both Quality Systems and GMP Quality would be ideal, though not required, for this position.
Essential Duties and Responsibilities:
- Own and lead all Quality System activities, including Document Control, Training, and change management.
- Provide and execute innovative ideas to advance document process efficiencies and incorporate best practices.
- Lead enhancements to Quality Systems to improve efficiency, regulatory compliance, and reduce manual processes.
- Work with cross functional groups to evaluate training assignments, develop and maintain training matrices, and drive training completion timelines.
- Reconcile and drive closure of document changes, formatting of controlled documents, and maintaining external and legacy controlled documents.
- Manage and lead migrations and transfers of controlled documentation into electronic document management system for retention.
- Provide and manage Quality Assurance support in the drafting and periodic reviews of controlled documentation, including SOPs, WIs, and Corporate Policies, and the review and approval of controlled documents.
- Manage the identification and retention of CMC and technical/development documentation.
- Perform QC reviews of requested documents (i.e., technical, regulatory, clinical).
- 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.
- Provide Quality Assurance support of clinical trials, through review and release of clinical trial documentation, review and release of production records for clinical kits and chemical solutions, and clinical product adjudication
- Assist with the organization, preparation, coordination, and documentation of regulatory agency inspections.
- Support the preparation, review and submission (as necessary) of regulatory agency documentation.
- Author and manage to resolution quality events related to Quality Systems including deviations, CAPAs, investigations, and change controls.
- Develop and deliver training and/or site guidance on document and records management roles and processes
- Create periodic reports for Training and Document Control to track, trend and follow up with personnel as needed.
- Bachelor’s degree or equivalent
- 6 years (Senior Manager) to 10+ years (Associate Director) of relevant work experience in the biotechnology, pharmaceutical, or life sciences industry, with experience in early clinical phases through commercial drug product preferred
- 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. A background in GMP Quality is preferred.
- Proficiency and experience with electronic Quality Management System implementation, management, and maintenance.
- Ability to lead organizational and process initiatives related to Quality Systems and Document Control.
- Experience with FDA and/or other regulatory agency inspections and inspection readiness activities.
- Strong leadership with ability to motivate, lead, and work in a matrix environment.
- Proficiency with Microsoft Outlook tools (Excel, Word, Vision, Project, SharePoint, Teams, and PowerPoint.
OnKure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancer. Using its proven structure-based drug design approach, the Company is building a robust pipeline of tumor-agnostic candidates that are designed to achieve optimal tolerability and efficacy. OnKure is currently developing its lead clinical candidate, OKI-179, an oral, selective Class I HDAC inhibitor, for the treatment of both hematological and solid tumors.
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), self-managed paid time off, and a 401(k) plan with company match. We operate on a flexible schedule that allows a combination of both in-office and home-based work. However, this is not a remote role, therefore the successful candidate must live in or be willing to relocate to the Boulder, CO area.
The level and annual compensation range for this role, based on experience, is $130,000-$160,000.
OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected factors.