Kura Oncology

Kura Oncology

Senior Manager, Clinical Quality Assurance

Boston, MA or Remote · Senior

Sponsorship not specified$160k-$187kDetected 34 days ago
GCPAuditingProcess ImprovementFDA RegulatoryPharmacovigilanceCommunicationInternal Audit

About the role

  • Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines?
  • 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 base range for this role at a Senior Manager level is $160,000 - $187,000.

Responsibilities

  • Develop collaborative partnerships with clinical study teams to provide GCP compliance guidance and advice across assigned clinical programs.
  • Support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance
  • Support clinical inspection readiness activities for assigned programs and other key programs as applicable.
  • Ability to manage multiple projects and demanding timelines.
  • Serves as a key point of contact for cross-functional partners within their area; ensuring alignment and proactively addressing coordination needs to support tea deliverables.
  • We are goal-focused and deliver with excellence

Requirements

  • BA/BS degree required, advanced degree a pllus
  • A minimum of 6-8 years of experience in the bio-pharmaceutical R&D industry with at least 3 or more years in a current, hands-on in a manager-level GCP Quality Assurance
  • Working knowledge of Veeva (or similar QMS e-system) required.

Compensation

  • Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

Benefits

  • Experience preparing for, participating in, and subsequent response to health authority GCP/GVP inspections/partner audits.
  • Generous stock options
  • 20 days of PTO to start

Company info

  • We are science-driven courageous innovators
  • We strive to bring out the best in each other and ourselves
  • Career advancement/ development opportunities

This listing is sourced directly from Kura Oncology's careers page and normalized into a canonical job model.