Quality Validation Leader III - Onsite Mississauga

Thermo Fisher Scientific•Mississauga, ON

1d•CA$69,400 - CA$92,500•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. As a Quality Validation Leader II at Thermo Fisher Scientific, you will provide Quality oversight for validation project deliverables that support our mission of making the world healthier, cleaner, and safer. In this role, you will be responsible for the Quality review and approval of GMP documentation, including protocols, reports, and master documents related to equipment commissioning, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Cleaning Validation. You will serve as the Quality liaison for cross-functional project teams, providing guidance on Quality-related questions and supporting the review and approval of protocol and qualification deviations. You will also act as the Quality reviewer and approver for facility, utility, and site-related deviations. This role requires strong collaboration across functions to support project execution, build effective stakeholder relationships, and maintain high standards of Quality and Compliance. Your expertise in Quality Assurance, validation, and regulatory expectations will be critical to delivering projects that enable business growth, operational excellence, and compliance with GMP standards.

Requirements

Bachelor’s degree in Science, Engineering, Chemistry, or a related field required.
Minimum of 5 years of Quality Assurance experience within the pharmaceutical industry.
Experience with equipment qualification, validation, and cleaning validation.
Proven ability to lead and influence cross-functional teams.
Strong communication and interpersonal skills, with the ability to engage effectively across all levels of the organization.
Strong organizational, analytical, and problem-solving skills with excellent attention to detail.
Ability to manage multiple high-priority projects simultaneously.
Proactive approach to risk identification, mitigation, and issue resolution.
Proficiency with Microsoft Office applications and project management tools.
Strong knowledge of Good Manufacturing Practices (GMP) and United States Food and Drug Administration (FDA) compliance expectations.
Proficiency in English communication required.

Nice To Haves

Preferred fields of study include Science, Engineering, Chemistry, or a related technical discipline.
Experience working in a regulated industry, such as pharmaceutical or medical device manufacturing, preferred.
Knowledge of GMP, GLP, ISO, and other applicable quality standards preferred.
Additional language skills are a plus.

Responsibilities

Provide Quality oversight for validation project deliverables.
Responsible for the Quality review and approval of GMP documentation, including protocols, reports, and master documents related to equipment commissioning, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Cleaning Validation.
Serve as the Quality liaison for cross-functional project teams, providing guidance on Quality-related questions.
Support the review and approval of protocol and qualification deviations.
Act as the Quality reviewer and approver for facility, utility, and site-related deviations.
Collaborate across functions to support project execution.
Build effective stakeholder relationships.
Maintain high standards of Quality and Compliance.