Change Control Manager

Grifols

. Perform technical management and supervision of change controls, including changes to processes, systems and technology, work roles, and organization structures .

Posted 10/26/2026full-timeMississauga • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Change Control processes within the pharmaceutical industry, ensuring compliance with regulatory standards and effective management of product licenses. Capable of leading teams, coordinating evaluations, and implementing quality monitoring protocols.

Highest-signal resume keywords

Change Control ManagementRegulatory Impact AssessmentQuality Management CertificationCGMP KnowledgeTechnical Leadership Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Change Control ProcessesRegulatory ComplianceData EvaluationStudy Protocol DevelopmentProcess Performance MonitoringSOP UnderstandingQuality AssuranceImplementation ControlProduct Quality MonitoringTechnical Documentation

Soft Skills

Organizational SkillsTime ManagementEffective CommunicationTeam CollaborationIntegrity and Commitment to Quality

Tools & Technologies

MS Office

Certifications & Qualifications

Bachelor's Degree in Health-related SciencesPost-Graduate Certification in Quality Management

Industry Keywords

Pharmaceutical IndustryHealth Competent AuthoritiesBlood Establishment LicensesCGMP RequirementsQuality and Compliance

About the role

Key responsibilities & impact

Perform technical management and supervision of change controls, including changes to processes, systems and technology, work roles, and organization structures
Determine and evaluate the impact of changes and their implementation on product licenses approved by Health Competent Authorities
Establish a defined change control process to approve or reject changes and involve appropriate stakeholders, including Manufacturing, Quality, and Regulatory Affairs
Coordinate reception of change control requests and determine involved areas for further evaluation
Compile global evaluations and determine regulatory impact on final product licenses and Blood Establishment licenses
Determine existing or new data needed to support changes and develop study protocols with methods and prospective acceptance criteria
Define additional post-implementation process performance and/or product quality monitoring as necessary
Control that all steps for final implementation are completed before implementation
Review implemented changes for alignment with study protocols and documentation
Assess generated data to demonstrate change objectives and acceptance criteria were met
Provide guidance to Quality specialists under his/her responsibility

Requirements

What you’ll need

Bachelor's Degree in Health-related Sciences
Post-Graduate Certification in Quality Management
Knowledge of cGMP requirements preferred
Minimum of 4 years of Management or technical leadership experience is required
Minimum of 6 years of related experience in Change Controls field in the pharmaceutical industry
MS Office knowledge
Organized and able to manage time effectively
Ability to work within a highly regulated, labor-intensive environment
Ability to understand, explain, follow, and enforce SOPs and protocols
Ability to plan, communicate and execute activities for the improvement of overall operations
Strong integrity and commitment to Quality and Compliance
Ability to work in groups and with other departments
Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups