Sr Mgr/Associate Director, GMP Quality Assurance

Boston, MA, United States

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 $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

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 discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.

Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at www.kuraoncology.com.

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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