29 Oct
|
Grifols
|
Mississauga
29 Oct
Grifols
Mississauga
Lead pharmaceutical change controls at Grifols in Winnipeg, evaluating regulated process, system, technology, and organizational changes. Apply quality and compliance expertise.
Reporting to the Corporate Quality Director, the Change Control Manager provides technical management and supervision for changes affecting product licenses. The role coordinates Manufacturing, Quality, and Regulatory Affairs stakeholders while assessing regulatory impact. It also determines supporting data, protocols, acceptance criteria, and monitoring requirements.
Key Responsibilities:
- Establish change control processes involving appropriate cross-functional stakeholders
- Coordinate requests and identify areas requiring further evaluation
- Assess regulatory impact on product and blood establishment licenses
- Develop protocols, acceptance criteria, and monitoring requirements
- Verify implementation, documentation, data, and change objectives
Requirements:
- Bachelor's degree in health-related sciences
- Post-graduate certification in quality management
- At least six years' pharmaceutical change control experience
- At least four years' management or technical leadership experience
- Knowledge of cGMP, MS Office, SOPs, and protocols
Bring pharmaceutical change control, regulatory assessment, and quality leadership expertise to Grifols' regulated operations in Winnipeg.
📌 Pharmaceutical Change Control Manager (Mississauga)
🏢 Grifols
📍 Mississauga