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
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