At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
In this individual contributor position you will be part of Pharma Technical Quality (PTQ) and will oversee the delivery of high-quality products and ensure operational excellence. You will be an experienced professional in pharmaceutical manufacturing and compliance. You should be able to leverage external partnerships to maximize global network capability and reliably deliver products to patients. Driven by a passion for quality and continuous improvement, you will ensure flexibility, compliance, and excellence in execution.
The Opportunity:
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You will serve patients through external partnerships to ensure access to quality products and offer flexibility to internal capacity.
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You will provide Quality and Compliance oversight for Roche products at Contract Manufacturing Organizations (CMOs), ensuring cGMP compliance.
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You will act as the Quality Single Point of Contact (SPoC) for designated CMOs, supporting the entire CMO lifecycle.
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You will develop and maintain Quality Agreements with CMOs and manage Make Assess Release (MAR) activities.
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You will oversee technical product transfer, validation, and GMP activities, holding CMOs accountable for compliance.
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You will collaborate with CMO and internal teams, managing relationships and resolving quality issues.
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You will provide QC expertise in investigations and ensure timely closure of deviations, complaints, and CAPAs.
Who you are
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You will have a B.A. or B.S. degree in life sciences or a related scientific discipline.
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You will bring 5 years of progressive experience in the biopharmaceutical or related industry or an equivalent combination of education and experience. Preferred experience with contract manufacturing organizations.
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You will have sound knowledge of Quality Control activities performed by CDMOs/CLOs
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You need to be highly competent in MS office applications including Excel, PowerPoint, Word, MS Project, etc.
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Fluent in oral and written English is a must.
Travel:
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Travel is required about 5-10%, mostly regionally
Relocation benefits not eligible for this position
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.
Roche is an Equal Opportunity Employer.
