Assoc. Dir, External Quality

Job Description

Position Overview - Basic Functions & Responsibility

Essential function(s) includes, but is not limited to:

The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.

The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g. small molecules, therapeutic proteins, biologics, vaccines, devices, combination products, sterile p...