Quality Assurance Specialist - Supplier Quality

Roche • Mississauga, ON

2d • $115,328 - $151,368 • Hybrid

About The Position

At Roche, we foster a culture where you can be yourself, embraced for your unique qualities. Our environment encourages personal expression, open dialogue, and genuine connections, ensuring you are valued, accepted, and respected. This allows you to thrive both personally and professionally as we work to prevent, stop, and cure diseases and ensure global access to healthcare. As a Quality Assurance Specialist - Supplier Quality, you will be instrumental in driving compliance excellence across our external supplier network (Direct Materials and Service Providers) and safeguarding product quality throughout the supply chain. This versatile role offers a unique opportunity to combine hands-on supplier oversight with enterprise-wide quality leadership, including strategic initiatives such as quality due diligence and early-stage program support. You will serve as a trusted expert in supplier regulatory compliance and operational excellence, directly impacting our mission to deliver safe, high-quality products to patients.

Requirements

• Hold a Bachelor's degree in life sciences, pharmaceutical sciences, chemistry, or have equivalent professional experience demonstrating comparable knowledge in a related industry.
• Demonstrated experience managing supplier and service provider relationships.
• At least 5 years of industry experience, with direct expertise in managing external suppliers and a deep understanding of supplier quality management and compliance.
• Comprehensive knowledge of cGMP, ISO standards, and international pharmaceutical regulations, with a proven ability to interpret and apply these standards to supplier environments.
• Excellent communication skills (fluent in oral and written English) to articulate complex quality concepts clearly to diverse audiences, from regulators to internal leadership.
• Proficiency with standard office tools (Microsoft Office or Google Suite).
• Availability for occasional domestic or international travel (up to 10% annually) to conduct audits and oversee quality on-site.

Nice To Haves

• Demonstrated experience managing supplier and service provider relationships is highly valued.

Responsibilities

• Oversee quality activities from supplier (Direct Materials and Service Providers) selection through decommissioning, including process validations, audits, Health Authority inspections, investigations, and regulatory submissions.
• Create, negotiate, and sustain Quality Agreements with external suppliers and partners, rigorously monitoring compliance and addressing any deviations or gaps.
• Manage critical quality functions for product release, such as batch review, investigation resolution, and change assessment, ensuring strict cGMP compliance.
• Collaborate with external suppliers to keep manufacturing processes, specifications, and analytical methods in a validated, regulatory-compliant state.
• Develop and maintain quality risk management plans to proactively identify and mitigate supplier compliance risks while driving continuous operational excellence.
• Expand your impact through strategic initiatives, such as conducting quality due diligence for business development and representing Quality on early-stage Technical Development Teams.
• Build strong relationships across internal and external partners to align quality expectations and quickly drive the interdepartmental resolution of complex regulatory challenges.

Benefits

• A healthier future drives us to innovate.
• Advance science, ensuring everyone has access to healthcare today and for generations to come.
• Empower each other to explore new possibilities, foster creativity, and keep our ambitions high.
• Deliver life-changing healthcare solutions that make a global impact.
• Scientific rigor, unassailable ethics, and access to medical innovations for all.

What This Job Offers

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