Pharmaceutical Control Manager

Position: Pharmaceutical Change Control Manager
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.