Senior Manager, Clinical Quality Assurance

Essential Job Functions

Reporting to the Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (CQA) is responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs. The incumbent builds collaborative, supportive relationships and serves as a point of contact for Quality Assurance across clinical development programs and relevant departments including clinical development, trial operations, pharmacovigilance, clinical data sciences, and other relevant stakeholders. Supports and maintains a quality-focused culture and mindset across the organization.

• Develop collaborative partnerships with clinical study teams to provide GCP compliance guidance and advice across assigned clinical programs.
• Ensure compliance with clinical quality assurance activities including facilitating and supporting internal and external GCP audits/audit programs, as applicable.
• 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
• Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment).
• Assist with the development and tracking of trending and metrics of internal as well as external vendor quality issues.
• Support clinical inspection readiness activities for assigned programs and other key programs as applicable.
• Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and front room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable.

Job Specifications

• BA/BS degree required, advanced degree a plus
• 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
• Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs).
• Demonstrated knowledge and application of Global regulations and guidance for GCP (knowledge of GCLP and or GVP a plus).
• Direct experience in the conduct and reporting of internal and external audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and product quality.