Description
Our pharmaceutical client, has an opening for a Site Head of Quality Assurance role. This organization, one of the fastest growing pharmaceutical organizations on the east coast, is offering opportunities to be a key influencer on the companies next level of growth. Responsibilities Leads and oversees Quality Assurance, Quality Control, Stability Quality Lead for regulatory inspections, client audits and the site internal and external audit program. Prepares and approves responses to all external audit findings Directs the QA team to ensure the timely completion of investigations, batch record reviews and batch releases Contributes to the review and implementation of quality agreements with clients, contractors, and suppliers Provides direction quality metrics for the site. Independently identifies and initiates functional and cross-functional projects/task teams Review and/or approve deviations, out-of-specification reports, formal investigations, complaint investigations; Corrective Action/Preventative Action (CAPA) program and other reports as necessary. Qualifications Bachelors degree in science or engineering required, MS or PhD in science preferred 10-15 years of Pharmaceutical experience in Quality and Analytical 7 years of leadership experience CDMO experience required
