Vice President, Quality Assurance
Kura Oncology · San Diego, CA ·
- Seniority
- C level
- Employment
- Contract
- Category
- QA
- Experience
- 18+ years
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.
ESSENTIAL JOB FUNCTIONS:
- Leads the Quality Unit responsible for Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (cGMP), Good Pharmacovigilance Practices (GVP), and Computer Software Validation (CSV).
- Develops, implements, and manages the Quality System to the standards expected by Health Authorities to support clinical development, commercial operations, and the post-approval product lifecycle.
- Commercial product disposition and end-to-end quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution activities.
- Governance and quality oversight of the commercial supplier network, including CMOs, contract laboratories, packagers, distributors, 3PLs, and applicable specialty-pharmacy partners.
- Oversight of the commercial product quality lifecycle, including product complaints, investigations, returns, field alert reports, recalls, market actions, and counterfeit or product-integrity concerns.
- Provides Quality oversight for internal GCP, GMP, GLP, and GVP activities.
- Ensures appropriate Quality oversight of CMOs, laboratories, suppliers, packagers, distributors, 3PLs, and alliance partners
- Leads Inspection Readiness and/or Inspection Preparedness efforts.
- Acts as lead/Host contact for GxP site inspections.
- Manages Quality System Reviews and presents to Management.
- Evaluates GxP activities for continuous improvement opportunities to the Quality System.
- Ensures risk-based quality management (RBQM) is applied as appropriate to clinical studies.
- Manages critical GxP product-quality, data-integrity, safety, and compliance events
- Identifies potential Quality risks to strategic and/or operational plans and proposes options to mitigate risks.
- Manages GxP Quality personnel, activities, and budget.
JOB SPECIFICATIONS:
- Bachelor’s degree in a Life Sciences discipline or equivalent.
- A minimum of 18 years of relevant experience in a regulated biotech, or pharmaceutical industry in a Quality Assurance function.
- Clinical development, commercial launch, and marketed-product lifecycle experience with strong experience supporting NDA approvals, MAAs, commercial launches, and post-approval submissions
- Experience with developing, implementing, and maintaining GxP Quality System which ensures compliance to GxP and regulatory standards.
- Experience in managing, hosting and/or supporting Health Authority inspections.
- 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 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 demonstrate success with managing multiple projects simultaneously and other priorities.
- Ability to interact constructively and efficiently with co-workers within and across departments, Management, and Vendors.
- Owns and makes final decisions for the function, including those with significant impact on portfolio strategy, organizational priorities, and business outcomes.
- Leads cross-functional alignment at the executive level, partnering with senior leaders to drive integrated strategy and ensure execution against enterprise priorities.
- 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.
- Proficient in Veeva QualityDocs.
- Proficient in Word, Excel, PowerPoint, SharePoint.
- Ability to travel for both domestic and international business.
The base range for a Vice President is $325,000 - $372,000. 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.
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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 commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.
Through our deep understanding of cancer biology and decades of experience in precision oncology, we are studying the underlying causes of treatment resistance. This enables us to design smart combination regimens with other cancer therapies to target tumors from multiple directions, with the goal of improving long-term clinical benefit.
Kura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit Kura’s website at www.kuraoncology.com 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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