Senior Quality Specialist General Medicine VIE Contract
Core
Ensure quality and regulatory compliance for products manufactured by external contractors in North America, managing audits, agreements, and continuous improvement.
Role type
Senior Quality Specialist (Contract Manufacturing)
Builds
Quality systems and compliance frameworks for outsourced pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
client delivery
Required skills
cGMP knowledge, Quality Agreement negotiation, Contractor audit management, CAPA management, Project management, Complaint handling, Change control management, Deviation management
Preferred skills
Experience in third-party manufacturing quality functions, Knowledge of various dosage forms (oral, injectables, lyophilized)
Technologies
None stated
Responsibilities
Ensure quality and regulatory compliance of subcontracted products; Manage Quality System efficiency between Sanofi and subcontractors; Lead or participate in subcontractor audits and manage CAPAs; Develop and negotiate Quality Agreements; Support new product launches and onboarding/offboarding; Resolve quality issues impacting cGMP compliance.