Our client launched a First-in-Human (FIH) study last July that is going well.  It is a small molecule Alzheimer’s program. In support of that they need to continue to build/update their Quality Management System (QMS) and stay on top of their audit plan.

SCOPE & RESPONSIBILITIES:

• Maintenance of Quality Management System documents including policies, standard operating procedures and the Quality Manual
• Creating and overseeing the execution of the audit plan across GLP, GMP and GCP functions
• Review of CDMO/CRO documents where Quality oversight is required (but not necessarily be the signatory approver)
• Leadership of the Quality Committee including leading the investigation of any significant quality events and the execution of appropriate corrective and preventive actions (CAPA) as required.

SPECIAL REQUIREMENTS:

• Needs a true GxP person. (They are an N of one)

LOGISTICS:

• 9 months+ contract
• ~20 hours/week
• ASAP Start