Senior Manager, Clinical QA

Job Summary

To support the development and implementation of quality assurance processes, the full-time Senior Manager, Clinical QA will oversee compliance activities, facilitate audits, and foster collaborative relationships across clinical development programs, working either onsite in Boston, MA or remotely.

Key responsibilities

• Develop collaborative partnerships with clinical study teams to provide GCP compliance guidance across assigned clinical programs
• Ensure compliance with clinical quality assurance activities, including facilitating internal and external GCP audits
• Support clinical inspection readiness activities and assist with regulatory inspections of Kura Oncology products

Required qualifications

• BA/BS degree required; advanced degree preferred
• 6-8 years of experience in the bio-pharmaceutical R&D industry, with at least 3 years in a manager-level GCP Quality Assurance role
• Experience in drafting, reviewing, and optimizing standard operating procedures (SOPs)
• Knowledge of Global regulations and guidance for GCP, with direct experience in conducting audits and root cause analysis
• Working knowledge of Veeva or similar QMS e-system required