Job Description
Sr Mgr/Associate Director, GMP Quality Assurance
Join to apply for the Sr Mgr/Associate Director, GMP Quality Assurance role at Kura Oncology, Inc.
Sr Mgr/Associate Director, GMP Quality Assurance
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Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.
At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.
As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.
To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.
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 $125,000 - $161,089 and Associate Director is $161,650 - $192,933 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 Kura’s Values that are used for candidate selection and performance assessments: - We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package - Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”)
NPM1-mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R
NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R
NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R
NPM1-mutant and
KMT2A -rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with
PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at and follow us on X and LinkedIn.
Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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