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Added 13 mins ago
KG
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GRIFOLS, S.A.

Change Control Manager

Mississauga, ON, Canada

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Job details

Posting language: English
Posted: Oct 26, 2026

Original job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.

Position title: Change Control Manager

Reports to: Corporate Quality Director

Position Objective:

The Change Control Manager will perform technical management and supervision of change controls, including changes to processes, systems and technology, work roles, and organization structures, determining and evaluating the impact of these changes and their implementation on the product licenses approved by Health Competent Authorities.

Key Responsibilities:

Establish a defined change control process to approve or reject the change and involves appropriate stakeholders, including but not restricted to Manufacturing, Quality, and Regulatory Affairs personnel.
Coordinate the reception of change control request and determine the areas involved for further evaluation by each of them.
Compile global evaluation and determine if there is a Regulatory impact on the Final product licenses as well as in the licenses of Blood Establishments involved in the change.
Determine data (existing and/or to be newly generated) needed to support the change and accordingly develop study protocols describing the methods, prospective acceptance criteria as well as additional post-implementation process performance and/or product quality monitoring as necessary Control that all the steps to be taken for final implementation have been done before the implementation.
Ensure implementation by reviewing that the change as implemented remains aligned with the relevant study protocols, and relevant documentation and perform an assessment of data generated to demonstrate that the change objective and acceptance criteria were met.
Provide guidance to Quality specialists under his/her responsibility.

Required Skills, Qualifications and Experience:

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.

The salary range for this position is currently being assessed and will be disclosed upon completion of the compensation review process, in accordance with applicable transparency requirements.

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Location: NORTH AMERICA : Canada : Mississauga:CAWINNIP - Winnipeg

Learn more about Grifols

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More about this job

Responsibilities

Manage change controls across processes, systems, technology, roles, and organizational structures, coordinating evaluations with Manufacturing, Quality, and Regulatory Affairs. Assess regulatory and product-license impacts, define supporting data and study protocols, oversee implementation, verify outcomes against acceptance criteria, and guide Quality specialists.

Requirements

Requires a bachelor's degree in a health-related science and a postgraduate certification in Quality Management; knowledge of cGMP is preferred. Candidates need at least six years of pharmaceutical change-control experience and four years of management or technical leadership experience, along with strong communication, organizational, compliance, and cross-functional collaboration skills.

Skills

Change Control Management
Regulatory Impact Assessment
Pharmaceutical Quality
cGMP
Quality Management
Stakeholder Coordination
Study Protocol Development
Data Assessment
SOP Compliance
Process Improvement
Project Planning
Communication
Time Management
Microsoft Office
Teamwork

Visa sponsorship

Not detected in the job text

Keywords

Change Control
Pharmaceutical Industry
Quality Management
cGMP
Regulatory Affairs
Product Licenses
Blood Establishments
Manufacturing
Quality Assurance
Change Control Process
Stakeholder Coordination
Impact Assessment
Study Protocols
Acceptance Criteria
Process Performance Monitoring
Product Quality Monitoring
Implementation Verification
Standard Operating Procedures
Compliance
Process Improvement
Microsoft Office

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