A pharmaceutical company located in Cambridge, MA is looking to bring on a QA Consultant to their team for 6 months who will be responsible for developing, implementing, and overseeing the GCP, GLP, and GVP quality systems within the company.
Act as a subject matter expert within internal departments and external vendors such as CMOs and CROs
Assist with preparing and reviewing regulatory submissions for the FDA and other international health authorities
Head up a risk-based audit program that supports all clinical activities, as well as post approval development activities
Ensure FDA inspection-readiness
Develop and conduct training on all current compliance issues and regulations
B.S. with 10+ years of Quality experience in the pharmaceutical industry
GCP is a must, GVP is a plus
Prior experience conducting clinical site audits and clinical vendor audits
Prior experience in a leadership role
Accepting applicants at the Sr. Manager, Associate Director, and Director levels! The consultant is expected to start early June so don't miss your chance and apply now!
Total Quality Management
Provide Technical Guidance