Change Control Manager

Grifols; Mississauga; On-site; CAD 100,000 - 140,000; Full time

Job summary

Grifols in Mississauga, Canada, is seeking a Change Control Manager to lead change controls across processes, systems, and organization structures within a highly regulated pharmaceutical environment.

You will coordinate cross-functional teams, assess regulatory impact on licenses, develop study protocols, and ensure implementation aligns with approved plans while maintaining quality and compliance. Strong project leadership and knowledge of cGMP are required.

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 is required.
• Minimum of 6 years of related experience in Change Controls in the pharmaceutical industry.
• MS Office knowledge is required.

Responsibilities

• Establish a defined change control process to approve or reject the change and involve stakeholders across Manufacturing, Quality, and Regulatory Affairs.
• Coordinate reception of change control requests and determine areas for evaluation by involved parties.
• Compile global evaluation and determine regulatory impact on final product licenses and blood establishment licenses.
• Determine data needed to support the change and develop study protocols with acceptance criteria and post-implementation monitoring.
• Ensure implementation by reviewing alignment with study protocols and documentation, and assess generated data to show objectives were met.
• Provide guidance to Quality specialists under supervision.

Skills

Project leadership

Regulatory knowledge

Cross-functional collab

Change control

Education

Bachelor's Degree in Health-related Sciences

Post-Graduate Certification in Quality Management

Tools

MS Office

Job description

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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.

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.