Remote Quality Assurance Senior Manager

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Wed, Mar 31, 2021

This job expires in: 15 days

Job Category: Quality Assurance

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Education Level: Bachelors

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

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