Associate Quality Lead (Quality Assurance Programs)

Roche • Mississauga, ON

1d • CA$89,256 - CA$117,149

About The Position

At Roche, we foster a culture where individuality is embraced, and personal expression, open dialogue, and genuine connections are encouraged. We value, accept, and respect everyone for who they are, enabling them to thrive personally and professionally. Our mission is to prevent, stop, and cure diseases and ensure universal access to healthcare for present and future generations. Join Roche, where every voice matters. The Position: Are you ready to shape the future of quality management in healthcare? As an Associate Quality Lead within our Pharma Development Quality (PDQ) function, you will play a vital role in supporting the delivery of quality-focused strategies that reinforce trust in our Quality Management System (QMS). Working with a high degree of independence, you will collaborate with cross-functional teams to ensure our clinical and safety data meets rigorous global regulatory standards. In this dynamic position, you will have the unique opportunity to champion a culture of continuous improvement and innovation. By leveraging data analytics and digital tools, you will help optimize data collection and provide key insights that directly support our mission of delivering life-changing medicines to patients faster and more securely.

Requirements

• A Bachelor’s degree in a scientific or quality-related discipline, or an equivalent combination of education and 1-3 years' of experience.
• Experience within the pharmaceutical, biotech, or medical device industry, with a foundational understanding of product development and GxP regulations (e.g., GCP, GVP, MDR).
• Strong digital and data literacy, with the ability to interpret data and translate it into actionable quality insights.
• Exceptional organizational and execution skills, alongside a demonstrated ability to take ownership of projects proactively.
• Developing expertise in Critical to Quality (CtQ) factors and functional group operations.
• Fluency in written and spoken English, with strong presentation skills.

Responsibilities

• Implement Quality Strategies: Support the design, execution, and tracking of risk-based quality management strategies across the PDQ portfolio.
• Deliver Quality Assurance: Execute targeted activities to assess quality assurance status and generate confidence in our end-to-end systems.
• Manage Quality Data: Enhance data collection procedures, perform ad-hoc analyses, and deliver high-quality data insights to fulfil external regulatory needs.
• Present to Health Authorities: Demonstrate the effective implementation of quality strategies.
• Drive Compliance Projects: Participate in departmental or cross-functional compliance initiatives aimed at optimizing daily operations.
• Champion Innovation: Drive the adoption of innovative digital tools and technologies into daily workflows to foster a proactive quality culture.
• Foster Collaboration: Build and maintain an inclusive, supportive work environment while executing departmental goals and initiatives under limited supervision.
• Audit Execution: Utilize AI and automated tools to execute audits and synthesize audit evidence.
• Inspection Support: Provide logistical and compliance support for GCP inspections, including scribe duties and back-room document QC.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level