Quality Program Manager - Production and Process Controls SME
Core
Lead global quality initiatives and serve as the primary SME for Production and Process Controls across Abbott's divisions, ensuring regulatory compliance and process validation.
Role type
Senior Quality Program Manager / Production and Process Controls SME
Builds
Global quality management systems, validated manufacturing processes, and corporate quality policies
Domain
Healthcare manufacturing (Medical Devices, Pharmaceuticals, Nutrition)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, Equipment qualification (IQ/OQ/PQ), Statistical Process Control (SPC), Risk management (FMEA), Regulatory compliance (21 CFR 820, ISO 13485), Manufacturing operations, Change management
Preferred skills
Managerial/Supervisory experience, Cross-functional leadership, Global project management
Technologies
FMEA, SPC, Validation planning tools
Responsibilities
Lead cross-functional initiatives to improve process capability and compliance; Review and recommend process/equipment qualifications and validations; Maintain SME expertise on Production and Process Controls policies; Deliver training on Quality Systems and validation principles; Facilitate standardization of production control programs across divisions; Manage multiple global projects with significant financial impact.
Seniority
Senior, hands-on IC with management scope