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Senior Manager, Small Molecule CMC Compliance & Inspection Readiness
Karwell Technologies
📍
Boston, Massachusetts, United States
Location
Boston, Massachusetts
Posted
May 08, 2026
Commute
Local Area
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This job is in your area. Enjoy a short commute and work close to home.
Job Description
Responsibilities:
- Real-time Inspection Readiness.
- Develop, manage and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities.
- Work directly with CMOs and the Company Manufacturing Center on inspection readiness activities, including identification of potential inspection risks.
- Work with internal teams on key issues to ensure inspection readiness.
- Develop project management plans with key metrics.
- Provide PM oversight of readiness activities.
- Build and maintain dashboards.
- Contribute to ongoing maturity/growth of the inspection readiness program.
- Assist with developing and providing oversight of mitigation plans.
- Develop evidence binders for inspections.
- Suppo...