Associate Quality Lead (Quality Assurance Programs)

Roche • Mississauga, ON

10d • CA$89,256 - CA$117,149 • Onsite

About The Position

As an Associate Quality Lead within the 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

• Support the design, execution, and tracking of risk-based quality management strategies across the PDQ portfolio.
• Execute targeted activities to assess quality assurance status and generate confidence in our end-to-end systems.
• Enhance data collection procedures, perform ad-hoc analyses, and deliver high-quality data insights to fulfil external regulatory needs.
• Demonstrate the effective implementation of quality strategies.
• Participate in departmental or cross-functional compliance initiatives aimed at optimizing daily operations.
• Drive the adoption of innovative digital tools and technologies into daily workflows to foster a proactive quality culture.
• Build and maintain an inclusive, supportive work environment while executing departmental goals and initiatives under limited supervision.
• Utilize AI and automated tools to execute audits and synthesize audit evidence.
• 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