Senior Quality Engineer
Core
Provide quality assurance support for biologic therapeutics ensuring compliance with cGMP, ICH, and global regulations.
Role type
Senior Quality Engineer (Biopharmaceuticals)
Builds
Quality systems, supplier management processes, and regulatory compliance frameworks for biologic products.
Domain
Biopharmaceuticals / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, supplier qualification and auditing, root cause analysis, risk management, CAPA management, deviation investigation, internal and external audit execution, technical writing, process improvement.
Preferred skills
Certified Quality Engineer, Certified Auditor, computer system validation, Veeva, SAP, Trackwise.
Technologies
Outlook, Word, PowerPoint, Excel, Veeva, SAP, Trackwise
Responsibilities
Manage suppliers of materials and services using a risk-based approach; perform and support internal and external audits; support review and approval of Complaints, CAPA, Audit Findings, and Deviation investigations; guide and train personnel on auditing and root cause analysis; escalate quality issues based on risk and compliance assessment; ensure site metrics comply with internal requirements.
Seniority
Senior, hands-on IC
