Sr Quality Specialist
Core
Provides technical leadership and quality oversight for a sterile manufacturing environment, ensuring compliance with pharmaceutical regulations to prevent regulatory actions and maintain product quality.
Role type
Senior Quality Specialist – Project Lead
Builds
Sterile injectable, oral solid dose, and softgel drug products from development to commercialization
Domain
Biopharma / Contract Development Manufacturing Organization (CDMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, regulatory compliance knowledge, quality systems expertise, technical writing, risk assessment, procedure development, staff training coordination
Preferred skills
CQA certification, Six Sigma training
Technologies
None explicitly stated
Responsibilities
Lead moderate complexity projects involving compliance assessments and regulatory decision-making; Review and approve procedures, training documents, forms, deviations, and change controls; Perform risk assessments for product quality and safety; Act as a technical resource for new product introductions; Coordinate group operations and provide staff training
Seniority
Senior, hands-on IC with project lead responsibilities
