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.
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Pharmaceutical Change Control Manager in Mississauga employer: Grifols
Grifols is an exceptional employer that prioritizes employee growth and development, offering a collaborative work culture in the heart of Toronto. As a leader in healthcare solutions, we provide our team with unique opportunities to engage in meaningful work that directly impacts public health while ensuring compliance with industry regulations. Join us to be part of a dynamic environment where your expertise will be valued and your contributions will help shape the future of healthcare.
