Senior Manager, Quality
Core
Leading site quality operations and ensuring compliance, product quality, and continuous improvement across manufacturing processes for flexible single-use technologies.
Role type
Senior Manager, Quality (Manufacturing)
Builds
Manufacturing quality systems, regulatory compliance, and operational excellence for flexible single-use technologies.
Domain
Life Sciences / Bioprocessing / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems management, Root cause analysis, CAPA management, Risk management, Regulatory compliance (GMP/FDA/ISO), Team leadership, Data analytics, Audit support, Change control, Nonconformance management
Preferred skills
Medical device, bioprocessing, pharmaceutical, or single-use manufacturing experience, Advanced degree in Engineering/Life Sciences/Chemistry
Technologies
ISO 9001, ISO 13485, GMP, FDA regulations
Responsibilities
Lead and develop the site quality organization, Ensure site compliance with global regulatory requirements, Oversee quality systems including CAPA and validation, Partner cross-functionally to reduce cost of poor quality, Drive timely investigations and corrective actions, Mentor and coach quality leaders and team members
Seniority
Senior, hands-on IC with leadership responsibilities
