Manager, Clinical Quality

How You’ll Make a Difference

As our Manager, Clinical Quality, your mission is to support all GCP quality oversight as it relates to phase I, II and III clinical studies. Partnering with clinical and medical affairs, you’ll ensure our quality system provides sufficient oversight and is compliant with applicable regulations for our GCP programs and activities. 

What You’ll Do

• Act as a Clinical Quality lead by supporting study team compliance with national and international regulatory standards and guidance for cell therapy products. 
• Develop audit plans and audit strategy for ongoing clinical trials.  
• Performs initial and ongoing audit of clinical vendors.
• Coordinate, plan and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
• Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented.
• Participate in the development of clinical standard operating procedures, work instructions, forms, and templates.  
• Develop and conduct training for staff (GCP, Inspection Readiness training, etc.).
• Support preparation for and execution of regulatory inspections.
• Provide quality and regulatory compliance guidance to clinical colleagues.

Skills and Experience

• Bachelor’s degree and 6+ years’ experience working within GCP a pharmaceutical or biologics environment. Experience in Clinical Quality in a related industry (i.e. medical device or diagnostics) will be considered. More experienced candidates may be considered at the senior level.
• Experience implementing and integrating clinical quality systems in CBER regulated biotechnology companies.
• Knowledge of applicable GCP regulations and industry guidance.
• Demonstrated ability to assess risk and prioritize effectively, with the ability to work with aggressive timeframes and adhere to project deadlines in a fast-paced environment.
• Strong communication and presentation skills with good relationship-building.
• Ability to travel up to 20% of time.