Senior Manager, Clinical Quality Assurance and Quality Systems

About the role

The Senior Manager of Clinical Quality Assurance and Quality Systems will be responsible for maintaining GCP compliance of all Clinical Operations, including participating in standing and ad-hoc CRO and Study Team meetings; oversight of data flows, protocol amendment and deviation activities, and training plans; performing compliance review of study-related documentation; and overseeing clinical vendor qualification activities (audits, monitoring, recordkeeping, etc.).  This individual will also participate in enterprise level forums (Safety Review Board, Quality Management Review, etc.) and will lead audit and inspection preparation activities to ensure GCP inspection readiness.   

In addition to the primary GCP-specific responsibilities, this individual will also have accountability for assigned workflows and Quality Management Systems (QMS) improvement projects, including user administration in eQMS and oversight of IT systems compliance.  This role will report directly into the Vice President of Quality and will also have defined accountability to the broader COUR Leadership Team.   

What you'll do

• Ensure GCP compliance across all Clinical Operations activities, documentation, and data for early phase studies. 

• Own and continuously improve SOPs and execution documents related to a Risk-Based GCP Quality Program in alignment with ICH E6(R3). 

• Maintain inspection readiness, ensuring systems, processes, and study documentation meet next phase regulatory expectations. 

• Facilitate Safety Review Board and serve as Quality point of contact for Pharmacovigilance (PV) vendor. 

• Serve as process owner for Supplier Quality Management programs (including audits), as well as other assigned QMS workflows (Documentation, Training, Deviation/CAPA, Change Control, other). 

• Represent Quality and provide insight and action in defined cross-functional teams.  

• Monitor and trend KPIs related to clinical quality as part of Quality Management Review activities. 

• Collaborate with cross-functional teams (Clinical Operations, Regulatory, CMC, etc.) to provide quality guidance and drive compliant execution of clinical trials. 
• Provide Project and Program Management support to Quality Improvement projects and other assigned initiatives. 

Qualifications

• Bachelor’s degree in business, medical, or scientific field; advanced degree highly preferred  
• 8+ years of Pharma/Biotech industry experience with 5+ in direct Clinical Trial support roles, GCP certification and defined Quality role track record preferred.  
• Successful track record of ownership and continuous improvement of electronic systems, project workstreams, and/or operational processes   
• Strong background in systems-based validation  
• Experience in managing relationships and performance with GXP vendors/suppliers  
• Experience in or deep knowledge of conducting investigations into non-compliance events, evaluating impact and risk, and implementation of corrective actions.    
• Experience in monitoring and evaluating KPI/metrics and data trending, including reporting action-focused summaries in executive forums. 

The level of this position will be based on the final candidate’s qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.