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 stakeholdersCoordinate requests and identify areas requiring further evaluationAssess regulatory impact on product and blood establishment licensesDevelop protocols,



acceptance criteria, and monitoring requirementsVerify implementation, documentation, data, and change objectivesRequirements: Bachelor's degree in health-related sciencesPost-graduate certification in quality managementAt least six years' pharmaceutical change control experienceAt least four years' management or technical leadership experienceKnowledge of c GMP, MS Office, SOPs, and protocolsBring pharmaceutical change control, regulatory assessment, and quality leadership expertise to Grifols' regulated operations in Winnipeg.#J-18808-Ljbffr

📌 Pharmaceutical Change Control Manager (Mississauga)
🏢 Grifols
📍 Mississauga