Global Change Control Lead - Pharma Quality

Grifols, S.A; Mississauga; On-site; CAD 110,000 - 150,000; Full time

Job summary

Grifols, S.A. in Mississauga seeks a Change Control Manager to oversee technical management of change controls across processes, systems, and organization structures. You will assess impact on Health Authority licenses and coordinate with Manufacturing, Quality, and Regulatory teams to drive compliant implementations.

The role requires 6+ years in pharmaceutical change controls, 4+ years in leadership, and strong MS Office skills, with a focus on cGMP and quality compliance.

Qualifications

• Bachelor's degree in health-related sciences is required.
• Post-graduate certification in quality management is required.
• Knowledge of cGMP requirements preferred.
• Minimum of 4 years of management or technical leadership experience.
• Minimum of 6 years of related experience in Change Controls in the pharmaceutical industry.
• MS Office knowledge is preferred.

Responsibilities

• Establish a defined change control process with key stakeholders (Manufacturing, Quality, Regulatory Affairs).
• Coordinate reception of change control requests and identify involved areas for evaluation.
• Compile global evaluation and assess regulatory impact on licenses and Blood Establishments involved.
• Determine data needs and develop study protocols with criteria and monitoring plans.
• Ensure implementation aligns with study protocols and that acceptance criteria are met.

Skills

Leadership

Time management

Communication skills

Regulatory awareness

Education

Bachelor's degree in health-related sciences

Post-graduate certification in quality management

Tools

MS Office

Job description

Grifols, S.A. in Mississauga seeks a Change Control Manager to oversee technical management of change controls across processes, systems, and organization structures. You will assess impact on Health Authority licenses and coordinate with Manufacturing, Quality, and Regulatory teams to drive compliant implementations.

The role requires 6+ years in pharmaceutical change controls, 4+ years in leadership, and strong MS Office skills, with a focus on cGMP and quality compliance.