Senior Specialist, Digital and Data Quality
Core
Ensures quality and compliance of GMP computerized systems and supporting infrastructure across manufacturing, packaging, labeling, and laboratories to protect product quality and patient safety.
Role type
Senior Specialist, Digital and Data Quality (GxP Compliance)
Builds
Validated computerized systems and quality oversight for GxP business processes
Domain
Pharmaceutical manufacturing / GxP Compliance / Computerized System Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GAMP, cGMP Regulations, Change Management, Deviation Management, Quality Auditing, Risk Management, Regulatory Compliance, Computerized System Validation, Data Integrity (ALCOA), Manufacturing Quality Control
Preferred skills
Six Sigma, PMP, Project Management, Regulatory Inspection Leadership, Cross-functional Collaboration
Technologies
GxP compliant IT infrastructure, Automated Manufacturing Equipment, Automated Lab Systems
Responsibilities
Provide independent quality approval of validation documentation (policies, protocols, reports); Ensure operating procedures and plans maintain validated status; Review processes to verify compliance activities are effective; Support regulatory inspection and audit activities; Drive resolution of regulatory non-conformances; Mentor junior team members.
Seniority
Senior, hands-on IC with limited supervision