Reporting to the Sr. Director of GMP Quality Assurance. The Sr. Manager/Assoc. Director GMP Quality Assurance will collaborate with the CMC department and external Vendors to ensure oversight and compliance. You will manage GMP activities related to Regulatory Standard Materials, Intermediates, Drug Substances, and Drug Products. Incumbent will continuously improve and maintain Quality Systems related to GMP activities, maintain documentation for compliance with quality and regulatory standards, and will collaborate closely with internal cross-functional teams and management.

Essential Job Functions

• Plan and oversee day-to-day GMP activities of the quality function.
• Ensure appropriate quality oversight of external Vendors.
• Active member of GMP Vendor meetings.
• Review and approve Vendor GMP documentation.
• Review and approve Vendor and Kura GMP Quality Events.
• Review and approve executed batch records for associated Regulatory Standard Materials, Intermediates, Drug Substance and Drug Product and determine final batch disposition.
• Support adherence to Vendor Quality Agreements.
• Generate quality metrics and compile data for Quality System Reviews.
• Participate in Kura GMP sub-teams as the Quality Representative.
• Evaluate GMP activities for continuous improvement opportunities to the Kura Quality System.
• Provide QA leadership in all matters relating to product quality, disposition and release of materials and finished products.
• Provide QA review of CMC related sections of regulatory filings.
• Coordinate and manage compliance related activities in preparation for Health Authority inspections and support interactions during Health Authority inspections.
• Other Quality Assurance responsibilities as assigned.

Job Requirements

• BS/MS degree in a scientific discipline (e.g. chemistry, pharmaceutical sciences or similar).
• For Sr. Manager 8 , Associate Director 10 years of experience in regulated pharmaceutical manufacturing with significant GMP/CMC QA experience. QA oversight of CMO vendors and product disposition experience required.
• Demonstrated working knowledge of clinical and commercial manufacturing and quality processes, including US, EU, and ICH regulations and guidelines.
• Demonstrated ability to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines.
• Proficient in standard business and quality software (e.g. Veeva Quality-Docs, Word, Excel, PowerPoint, SharePoint).
• Demonstrates proven track record of quality leadership, communication, and motivation skills with internal and external Vendors.
• A good team player with a solid record of collaboration within and across internal teams and vendors. Ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
• Clear, concise writing skills and verbal presentation skills.
• Periodic travel to Kura offices, and vendors required. Must be able to travel internationally.

The base range for a Senior Manager is $136,344 - $148,611 and Associate Director is $173,690 - $188,180 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus