Country Quality Senior Manager – GMP & QMS (Canada)

Alexion Pharma Spain S.L.; Mississauga; Hybride; CAD 88 000 - 116 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Competitive base salary

Benefits package

Résumé du poste

Alexion Canada in Mississauga, ON is seeking a Senior Manager, Country Quality to lead the QMS and be the primary Quality contact for product release. The role requires strong GMP knowledge and Health Canada compliance, with matrix collaboration across functions and global quality initiatives.

You will maintain qms, oversee lot release, support inspections, and drive remediation plans while aligning with local GMP/GXP guidelines and launch activities.

Qualifications

• Minimum 6 years in QA/compliance within pharmaceutical/biotech.
• Experience with sterile and biological finished product processes.
• Deep knowledge of Health Canada GMP guidelines.

Responsabilités

• Maintain the QMS aligned with Corporate Quality and Health Canada GMP requirements.
• Lead lot release activities and QA tasks in compliance with regulations.
• Coordinate with Supply Chain to prioritize releases per business needs.
• Roll out and ensure ongoing compliance to global quality systems at site level.
• Support Health Canada GMP inspections and audits.
• Review and implement remediation plans from audits.
• Ensure SOPs are followed and aligned with local GMP/GXP guidelines.
• Support quality input for new product launches and cross-functional projects.
• Authorize return to saleable stock of returned products.
• Oversee supplier and customer qualification; maintain quality agreements.

Connaissances

GMP knowledge

QMS management

Deviation & CAPA

Health Canada regulations

Cross-functional collaboration

Effective communication

Global matrix work

Formation

Bachelor's degree in life science or pharmacy

Advanced degree preferred

Outils

QMS software

Documentation systems

Description du poste

Alexion Canada in Mississauga, ON is seeking a Senior Manager, Country Quality to lead the QMS and be the primary Quality contact for product release. The role requires strong GMP knowledge and Health Canada compliance, with matrix collaboration across functions and global quality initiatives.

You will maintain qms, oversee lot release, support inspections, and drive remediation plans while aligning with local GMP/GXP guidelines and launch activities.