Job Summary

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 sites
• Performing batch release through batch record and data review/approval and managing process deviations for timely release
• Reviewing and/or approving deviations, OOS, CAPAs, change control in an efficient manner for adequate and timely closeout of these events

Qualifications Include:

• Working knowledge of US CGMPs
• Extensive experience in the pharmaceutical/bio-pharm manufacturing industry with prior experience at the QA Manager level
• Experience working with Quality systems in support of both early and late stage development programs
• Relevant equivalent content experience, including managing contract manufacturers and external vendors
• In depth working knowledge of cGMPs, ICH guidelines and applicable EU/US regulatory requirements for biological products
• BSc or higher degree in biology, biochemistry, or other relevant scientific discipline