Senior Manager, Quality Assurance

Junto HLS is working directly with Leadership at a Top 20 pharma to recruit a Senior Manager, Quality Assurance.

Position Overview:

  • Managing all Oral Solid Dosage products from API through final packaging including the integration of new products.
  • Develop and implement strategic risk based lean approaches to the batch review and disposition process.
  • Serve as QA representative to cross functional project teams such as tech transfer, computer systems, process improvement, etc.
  • Identify and propose Quality process and system improvements by leading improvement projects.
  • Initiate, monitor and complete change controls related to Quality topics.
  • Monitor suppliers and lead off-site visits and teleconferences for discussion and review of supplier performance to established schedules and cGMP compliance.
  • Initiate, revise and review controlled cGMP documents including SOPs, Material Specifications, and investigation protocols and reports as applicable.
  • Partner with CMO’s to develop and monitor applicable quality metrics.
  • Identifies and facilitates continuous improvement efforts to improve CMO batch release metrics as needed.
  • Being accountable for the commercial API lot review and release process.
  • Participating in issue detection and resolution with API manufacturers.
  • Help to monitor and improve Quality Systems through data collection, calculation, and reporting on departmental performance metrics.
  • Participate on investigation teams and ensure proper close out and follow-up.
  • Review and approve process, assay, and other validation protocols and reports as applicable.
  • Prepare and review applicable sections of regulatory submissions and applicable sections of the Annual Product Review.


    • Greater Boston, MA

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