Director, Quality (PAI Readiness Focus)

SpyGlass Pharma, Inc.
Aliso Viejo, CA
Job Description
The Director of Quality is responsible for supporting SpyGlass Pharma's Pre-Approval Inspection (PAI) Readiness Program, ensuring the site and contract manufacturing organizations are robust and align with regulatory expectations for commercial manufacturing.

Requirements

  • Maintain expert knowledge of FDA, USP, cGMP, and other quality system standards and regulations, applying these to SpyGlass Pharma’s operations.
  • Support PAI readiness activities and ensure the site and CMO’s and Contract Labs are ready for PAI inspections
  • Accountable for execution of QMS Gap Assessment Activities.
  • Lead and coordinate successful gap remediation activities at both SpyGlass and contract manufacturers.
  • Identify risks and resolve QMS issues and appropriately communicate gating items to senior management and stakeholders.
  • Assist in the development and revision of SOPs and controlled documents to support GxP-regulated activities.

Benefits

  • Comprehensive health, dental, and vision insurance plans
  • Generous paid time off, including holidays, vacation days, and personal leave
  • Annual Bonus opportunity
  • Share in our success with stock options
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