Director, GMP Quality Assurance

San Diego, CA

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.

Director, GMP Quality Assurance

We’re looking for an innovative Director of GMP Quality Assurance to join our team at our San Diego office. This is a newly created position due to company growth and will report to the Head of Quality Assurance.

The Director will collaborate with the CMC department and external Approved Vendors (Vendor) to ensure oversight and compliance.  Director will manage GMP activities related to starting materials to the distribution of labeled investigational product.  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 executed batch/packaging/labeling records for Kura’s program and determine final batch disposition.
  • Review and approve Vendor and Kura GMP Quality Events.
  • Support adherence to Vendor Quality Agreements.
  • Collaborate with CMC team on requested QP documentation.
  • 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 regulatory agency inspections and support interactions during regulatory agency 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.
  • 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
  • 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.

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
  • 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
  • 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
  • Cell Phone and Wellness 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 Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. KO-539 is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for KO-539 at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.

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. To apply, please submit your resume to careers@kuraoncology.com