Vice President, Quality
About The Position
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This position is responsible for the strategic and technical leadership of all aspects of Quality Assurance & Quality Control for Denali’s therapeutic products and accountable for the strategic leadership of the function, building & managing appropriate Quality systems and overseeing activities to ensure safe & effective products are delivered to patients.
Requirements
- 20+ years relevant experience in GMP Quality or relevant functions, and experience in both biologics and small molecule quality is highly desirable and 15+ years of management experience
- Bachelor’s degree required, and advanced scientific degree desirable
- Broad understanding of international regulations and guidance
- Strong experience in IND and CTA filings. NDA/BLA/MAA experience strongly preferred
- Experience in auditing CMOs and managing internal audits desirable
- Excellent written and verbal communication skills
- Exceptional influencing, partnership, and collaboration skills
- Strong ability to prioritize workload and manage the growth & development of employees
- Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners
- Able to prospectively identify potential problems and to partner effectively and positively to solve issues
Responsibilities
- Ensure effective and efficient completion of key technical deliverables including Quality Agreements, batch record review, method validation
- Accountable for developing collaborative and productive partnerships across Denali as well as external contract manufacturing organizations, study site pharmacies, and QPs
- Identify & mitigate GMP risks
- Oversee the Quality Management System and modify & develop as needed to meet the growing needs of the organization
- Support investigational new drug applications (IND), ex-US clinical trial applications (CTA), new drug applications (NDA/BLA/MAA) and related correspondence from the US Food and Drug Administration (FDA) and other global regulatory authorities
- Manage internal and external audits
- Partner with external vendors in support of Quality document preparation and submission
- Maintain up-to-date knowledge of the Quality landscape, regulations, and guidelines
- Support development of specifications for biologics and small molecule programs
- Ensure compliance with relevant governing laws, regulations, guidelines, and Denali SOPs
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
Benefits
- Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
- Learn more at https://www.denalitherapeutics.com/careers
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What This Job Offers
Job Type
Full-time
Career Level
Executive
