Senior Manager/Associate Director, Clinical Quality Assurance (PV-GCP)

Role Summary

Senior Manager/Associate Director, Clinical Quality Assurance (PV-GCP) is responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight for pre- and post-marketing Pharmacovigilance activities, and will provide QA GCP support to assigned clinical development programs. The role may also support computer system assurance for applicable clinical/PV systems. This position partners with PV, clinical development, trial operations, clinical data sciences, and other stakeholders to promote a quality-focused culture.

Responsibilities

• Develop collaborative partnerships with PV and assigned clinical study teams to identify potential quality risk exposures within ongoing studies and across programs.
• Ensure compliance with pre- and post-marketing PV requirements and GCP activities, including facilitating internal and external PV/GCP audits.
• Implement and support QA activities that prioritize compliance, data integrity, and end-to-end quality assurance while protecting patient rights and welfare.
• Identify opportunities for process improvement, including issue escalation, corrective/preventive actions, and internal audit/gap assessments.
• Develop and track trending and metrics for internal and external vendor quality issues.
• Provide training on new regulatory requirements and industry practices.
• Lead PV inspection readiness activities and other key programs as applicable.
• Support regulatory inspections of Kura Oncology products, including back room/front room activities and drafting/reviewing responses to findings.
• Promote quality and risk management principles in innovative programs and ongoing clinical programs.
• Ensure risk-based strategies are used to manage and mitigate quality issues across clinical studies and programs.

Qualifications

• BA/BS degree required; advanced degree preferred.
• Senior Manager: minimum 6 years; Associate Director: minimum 8 years of experience in the biopharmaceutical R&D industry, with at least 4 years (6 for AD) in PV/GCP quality assurance for pre- and post-marketing PV activities.
• Minimum 2 years of experience leading teams, projects, programs, or direct reports.
• Experience drafting, reviewing, implementing, and optimizing SOPs.
• Knowledge of global regulations and guidance for GVP and GCP; understanding of validated computerized systems in clinical trials and PV activities.
• Experience conducting and reporting internal and external audits, root cause analysis, and translating findings into corrective actions to mitigate risks.
• Experience preparing for and responding to health authority GVP/GCP inspections or partner audits.
• Working knowledge of Veeva or similar QMS; familiarity with Inspection Management Tools is a plus.
• Ability to write clear quality position statements, risk-based audit reports, and procedures.
• Excellent oral and written communication; strong judgment, project management, and decision-making skills; ability to manage multiple projects and timelines.
• Operational experience in PV Operations, Clinical Operations, Data Management, and/or training within clinical and/or commercial settings is advantageous.

Education

• BA/BS degree required; advanced degree preferred.

Skills

• Clear written and verbal communication
• Quality assurance and compliance across PV and GCP domains
• Risk assessment and management, data integrity, and issue resolution
• Audit planning, execution, and corrective action implementation
• Cross-functional collaboration with clinical, PV, and data teams