QA Manager

Our Cell Therapy client in Houston, TX is looking to add a QA Manager to their growing team!  This role act as the primary QA CMC POC for the Houston site; with focus on GMP CMC activities related to oversight of internal and external and CMO/Vendor focusing on Batch disposition, and quality compliance in support of Cell Therapy programs.  Other responsibilities include but not limited to: 

 

  • Provide oversight/monitoring of GMP activities which includes internal and external (CMO, CDMO, and CTL), as appropriate
  • Effectively interact with external vendors on review and coordination of executed records
  • Conduct batch disposition/release activities for critical raw materials/starting materials, intermediates, drug substance, and drug product for all phases of development including review and approval of master batch records, test methods, and other associated executed records internally and externally
  • Act as primary/responsible QA SME reviewer and approver for Stability protocols, test results, and ancillary reports for Cell Therapy programs
  • Work as part of an internal multidisciplinary team to coordinate, conduct reviews, and approvals of documentation which supports associated GMP and/or development activities using Vendor Management Document System
  • Manage, review and approve GMP associated Deviations, Investigations, CAPAs, Change Controls, OOS/OOT, etc.
  • Implement/update necessary Quality Management Systems in support of improving the oversight responsibilities of contract vendors and on-site GMP operations (manufacturing, facility/utilities, quality control, etc.)
  • Capable of working in a startup environment with the ability to multi-task, prioritize, and execute with minimal guidance
  • Represent the QA CMC department on project teams as SME
  • Facilitate internal cross-department meetings (setting agendas, following-up on action items, and sending out meeting minutes) independently
  • Perform external vendor audits as lead or as co-auditor, dependent on level of experience
  • Assist in reviewing CMC sections of regulatory submissions, when applicable

Requirements:

  • Bachelor’s degree (BA/BS) in a scientific discipline or equivalent degree, and 8+ years’ experience in quality assurance. Ideal candidates will have Cell therapy experience. Biologics experience is a plus.
  • Able to multitask and support various projects and teams
  • Strong organizational and time management skills
  • Expertise with Microsoft Office; Word, Excel, and Microsoft Project
  • Experience with electronic document management systems a plus
  • Experience with an electronic compliance management system a plus