International Quality Lead

Roche•Mississauga, ON

1d•Hybrid

About The Position

At Roche, we advance science so that we all have more time with the people we love. In Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unrivalled transparency with health authorities, patients, and society. The Opportunity Are you ready to shape the future of quality management in healthcare? As a Quality Lead within our Pharma Development Quality division, you will support the Roche/Genentech organisation by developing and delivering robust Quality Assurance strategies, audits, and conclusions across molecules in development, post-approval products, and global processes. You will act as a trusted partner, ensuring our operations maintain the highest standards of compliance while directly influencing how we bring innovative therapies to patients safely and efficiently. In this dynamic role, you will apply a risk-based approach to Quality Assurance using our Critical to Quality (CtQ) framework. By generating actionable data and insights through audits, you will collaborate closely with international stakeholders and play a vital part in preparing for and supporting regulatory authority inspections. This is an exceptional opportunity to utilise your expertise in a truly global, agile matrix environment where your insights drive continuous improvement.

Requirements

A Bachelor’s degree or equivalent in a scientific or quality-related field, or equivalent combined experience.
Proven experience within the pharmaceutical, biotech, or medical device industry, with solid knowledge of end-to-end product operationalisation.
Strong exposure to and understanding of global GxP regulations and quality roles, specifically within GCP, GVP, or IVD/MD frameworks.
Excellent digital capabilities, with a good understanding of audit management and analytical reporting tools to drive data-led solutions.
Proven problem-solving, decision-making, and project management skills with the ability to navigate ambiguous information.

Nice To Haves

You look for opportunities to develop your skills within an international team and are passionate about continuous growth.

Responsibilities

Support the execution of risk-based Quality Assurance strategies and conclusions in predominantly Good Pharmacovigilance Practice (GVP) as well as Good Clinical Practice (GCP), using the Critical to Quality (CtQ) framework.
Plan, perform, and lead audits, grouping individual issues into systematic trends to provide valuable quality data that fulfils regulatory requirements.
Establish and maintain strong partnerships with business stakeholders, presenting audit observations and associated compliance risks clearly.
Play a key role in regulatory authority inspection preparation and management.
Participate actively in assigned departmental goals and initiatives, contributing directly to the continuous improvement of PDQ processes.
Maintain deep awareness and expertise in global regulations (such as FDA, EU, and ICH guidance) across GCP, GVP, or Medical Device frameworks.