Director, GMP Quality Assurance at Kura Oncology, Inc.

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.

We’re looking for an innovative Director of GMP Quality Assurance to join our team at our San Diego office. This position reports to the Head of Quality Assurance. Willing to consider candidates at the Senior Director level.

This person will collaborate with the CMC department and external Approved Vendors (Vendor) to ensure oversight and compliance. Director/Sr. Director will manage GMP activities related to Regulatory Standard Materials, Intermediates, and Drug Substance. Director/Sr. Director 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, and Drug Substance Kura’s program 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 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:

BA or BS degree in a scientific discipline or supplemental Quality education.
15+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience.
Extensive understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex) and other agency standards and guidances as they relate to quality systems/quality assurance
Experience with Health Authority filings and/or inspections.
Proficient in Veeva QualityDocs.
Proficient in Word, Excel, PowerPoint, SharePoint.
Demonstrates proven track record of leadership, communication, and motivation skills with internal and external Vendors.
A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with organization objectives.
Solves conflict and addresses workplace issues in professional and collaborative manner
Flexibility and ability to provide a solution-based approach to emerging challenges and changing priorities.
Clear, concise writing skills and good verbal presentation skills.
Self-motivated, detail oriented, well organized, and able to demonstrates success with managing multiple projects simultaneously and other priorities.
Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Vendors.
Communicate decisions and recommendations with clear justification.
Ability to resolve day-to-day issues efficiently while maintaining compliance.
Independently determines and develops approach to solutions.
Proactive approach to problem solving.

This role's annual base salary range is $214,984 - $223,286. 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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