About COUR

COUR is a clinical stage biotech company with a mission to restore health in autoimmune patients by developing first-in-class, disease-modifying, targeted therapies to safely regulate and calm the immune system.  Our portfolio consists of three mid-to-late-stage proprietary programs: PBC, myasthenia gravis (MG), and type 1 diabetes (T1D), and our platform positions us to broaden our impact in antigen-specific autoimmune conditions.

About the role

As the Senior Manager, Quality Systems at COUR Pharmaceuticals, you will play a crucial role in ensuring that our operations, documentation, and data are late-stage inspection ready. You will serve as the system owner for electronic QMS and data platforms, and as the process owner for our Quality Management Review and Supplier Quality Management (including Audit) programs. Your contributions will support both preclinical research and early-stage manufacturing processes. This role will report to Vice President, Quality; and be part of the leadership team within Quality.

What you'll do

• Oversee the use and continuous improvement of processes and electronic systems associated with Document Management, Training, Change Control, and Deviation/CAPA. 
• Own and oversee use and continuous improvement of Data Governance, Supplier Quality, Risk Management, Audit/Self-inspection, and Validation processes and electronic systems.   
• Own and lead Quality Management Review process and related KPI trending and reporting forums.   
• Build and lead a small team of both FTE and contract specialists. 
• Lead and/or participate in supplier and internal audits.   
• Represent Quality and provide insight and action in defined cross-functional teams. 
• May have responsibility for aspects of EH&S program, depending on experience 

Qualifications

• B.S or M.S. in Engineering, Science, or Regulatory Compliance 
• 8+ years of Pharma/Biotech industry experience with 5+ in Quality roles 
• Track record of ownership of eQMS systems and/or workflows 
• Strong background in systems-based validation 
• Experience in all aspects of Supplier Quality Management, including strategic planning, vendor evaluation/qualification, ongoing interaction and oversight, quality agreement ownership and application, and risk management. 
• Biotechnology/pharma industry experience in investigation/root cause analysis as well as trend analysis for continuous improvement.   
• ASQ or similar Auditor certification a plus 
• Background in EH&S compliance a plus but not required

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. 

 Why Join COUR? 

·        Be part of a pioneering team developing revolutionary therapies with the potential to cure autoimmune diseases. 

·        Collaborate with top-tier academic and clinical partners. 

·        Contribute to science that has the potential to transform patients' lives. 

·        Engage in an inclusive and dynamic work environment that fosters learning and growth.