Sr Specialist, Quality Systems
Core
Oversees the lifecycle management of GXP suppliers and service providers, including audits, qualifications, and corrective actions.
Role type
Senior Specialist, Quality Systems (Supplier Quality)
Builds
Supplier quality lifecycle management programs and audit results
Domain
Pharmaceutical/Biotechnology Quality Systems
Required skills
Supplier lifecycle management, External audit management, CAPA and root cause analysis, Quality agreements, Supplier qualification, Regulatory compliance (cGMP, FDA, EU), Data analysis and KPI reporting, Technical writing
Preferred skills
Lead auditor qualification, eQMS experience, Lean/OPEX or Six Sigma, Risk management tools (FMEA, HACCP)
Responsibilities
Manage supplier lifecycle from qualification to offboarding, Conduct or support supplier audits, Oversee external audit programs, Lead complex internal investigations and CAPAs, Write and revise controlled documents (SOPs), Represent quality at regulatory inspections, Provide supplier quality metrics for management reviews
Seniority
Senior, hands-on IC