Sr Manager, Compliance
Core
Conducting independent internal audits of global pharmaceutical manufacturing and clinical trial sites to identify systemic quality/compliance gaps and ensure adherence to GMP and regulatory standards.
Role type
Senior Manager, Pharma-GMP Auditor and Risk Management Leader
Builds
Independent audit program for Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites
Domain
Pharmaceutical manufacturing, Quality Assurance, Regulatory Compliance, GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical GMP auditing, risk management, quality investigations, root cause analysis, audit reporting, data integrity auditing, sterile manufacturing knowledge, regulatory inspection hosting/support
Preferred skills
Experience in aseptic practice, biologics cell culture, viral vector manufacturing, IT system validation, advanced degree in Pharmacy/Science/Engineering
Technologies
GMP, ISO, ICH, FDA, EMA, MHRA, AIFA, ANVISA regulatory frameworks
Responsibilities
Conduct internal audits of manufacturing and clinical trial sites, prepare detailed audit reports, maintain knowledge of emerging quality regulations, participate in ad-hoc quality compliance projects, train internal/external auditors
Seniority
Senior, hands-on IC with leadership responsibilities
