Lead pharmaceutical change controls at Grifols, applying quality management and regulatory impact assessment across processes, systems, and technologies.

Reporting to the Corporate Quality Director, this manager supervises technical change control activities affecting product and Blood Establishment licenses. The work coordinates Manufacturing, Quality, and Regulatory Affairs stakeholders while evaluating implementation requirements.

You will develop study protocols, assess generated data, and guide Quality specialists.

Key Responsibilities:

- Establish processes to approve or reject proposed changes
- Coordinate requests and identify areas requiring evaluation
- Evaluate regulatory impacts on product and establishment licenses
- Develop protocols, acceptance criteria,



and monitoring requirements
- Verify implementation alignment and assess generated data

Requirements:

- Bachelor’s degree in health-related sciences
- Postgraduate certification in quality management
- Six years’ related pharmaceutical change control experience
- Four years’ management or technical leadership experience
- Knowledge of cGMP requirements and MS Office

Bring regulated pharmaceutical change control leadership, protocol development, and compliance expertise to Grifols’ quality organization.

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