Remote Quality Assurance Senior Manager

Company: Orchard Therapeutics plc
Location: Gary
Posted on: April 10, 2021

Job Description:

A company dedicated to development of gene therapies is seeking a Remote Quality Assurance Senior Manager. Core Responsibilities of this position include:Reviewing and approving master batch records, master labeling/packaging records, product specifications and other process related documents from contract sitesPerforming batch release through batch record and data review/approval and managing process deviations for timely releaseReviewing and/or approving deviations, OOS, CAPAs, change control in an efficient manner for adequate and timely closeout of these eventsQualifications Include: Working knowledge of US CGMPsExtensive experience in the pharmaceutical/bio-pharm manufacturing industry with prior experience at the QA Manager levelExperience working with Quality systems in support of both early and late stage development programsRelevant equivalent content experience, including managing contract manufacturers and external vendorsIn depth working knowledge of cGMPs, ICH guidelines and applicable EU/US regulatory requirements for biological productsBSc or higher degree in biology, biochemistry, or other relevant scientific discipline

Keywords: Orchard Therapeutics plc, Gary , Remote Quality Assurance Senior Manager, Executive , Gary, Indiana