Senior Manager, Country Quality (Canada)
Core
Manage the Corporate Quality Management System (QMS) and ensure compliance with Health Canada GMP requirements for product release and manufacturing operations.
Role type
Senior Manager, Quality Assurance
Builds
Pharmaceutical/biotech products (sterile and biological finished products)
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP compliance, QMS management, Deviation Management, CAPA, Change Control, Health Canada regulations, Lot release, Supplier qualification, Quality agreements
Preferred skills
Advanced degree in life science or pharmacy, Experience with EMA/FDA/PMDA regulations
Technologies
QMS software, GMP documentation systems
Responsibilities
Maintain QMS in line with Corporate Quality and Health Canada GMP requirements, Manage QA related tasks including lot release activities, Coordinate with Supply Chain to prioritize lot release, Support coordination and management of Health Canada GMP inspections, Manage review and implementation of Quality Improvement/remediation plans, Ensure implementation of Alexion Policies and Global Quality Standards SOPs, Support quality oversight for new product launches, Authorize return to saleable stock of returned medicinal products, Approve and maintain quality agreements with vendors
Seniority
Senior Manager, hands-on leadership