CDMO Quality Lead- North America

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 people leader role you will ensure Quality and Compliance of Good practices (GxP) activities for Pharma Global Technical Operations, empowering and inspiring your team. Reporting to the Head of External Quality, you play a key role in crafting and implementing Contract Development and Manufacturing Organization (CDMO) quality oversight strategies while acting as a strategic partner to internal and external stakeholders to support various organizational priorities. Leading a team of approximately 15 members, you ensure "Right to Operate" with a customer focused approach.

The Opportunity:

• You will ensure (GxP) compliance per Good Manufacturing Practice (cGMP), Roche standards, and health authority regulations, identifying and communicating GMP compliance gaps.
• You will monitor material quality, partner with GxP Suppliers to improve process capability, and deliver clinical development projects, Licensing/Partnering assessments, Technical Transfer, and Product Launch projects.
• You will establish and conduct Quality Governance within External Quality, collaborating with Leads and Stakeholders to meet team and organizational needs.
• You will develop a roadmap for efficiency and effectiveness through continuous improvement and harmonization of systems, processes, and tools.
• You will represent Roche/External Quality at business reviews, influencing decisions to drive consistent performance and customer satisfaction.
• You will ensure timely delivery of quality products, manage end-to-end GMP activities, and oversee external supplier events and issue management processes.
• You will manage team processes related to selection, hiring, training, and development, fostering an agile approach and demonstrating VACC leadership behaviors

Who you are

• You hold a B.A. or B.S. degree in life sciences, Pharmacy, or a related scientific field with 12 years of experience in the Pharma/Biopharmaceutical industry, including 7 years in Quality, Compliance, Regulatory, or Validation.
• You have significant experience in leading teams in a matrix environment and a deep understanding of quality assurance concepts such as cGMP and GDP.
• You possess technical manufacturing knowledge and experience across multiple technical platforms and product life cycles.
• You have the ability to establish and articulate a vision, set goals, develop and implement strategies, and track and measure results.
• You demonstrate strong creative leadership skills (VACC model), with excellent collaboration, coaching, and communication skills to build empowered teams and influence at all levels.

Travel up to 25% (domestic and international)

Relocation benefits are not available 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.