CMO Quality Site Manager (Specialist)

F. Hoffmann-La Roche Gruppe; Ontario; On-site; CAD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company dedicated to advancing healthcare and ensuring quality in pharmaceutical manufacturing. This role offers the opportunity to leverage your extensive experience in Quality Control and compliance oversight while managing relationships with Contract Manufacturing Organizations. You will play a crucial role in ensuring that high-quality products are delivered to patients, driving continuous improvement and operational excellence. If you're passionate about quality and innovation, this position is a perfect fit for you.

Qualifications

• 5-7 years of experience in biopharmaceutical or related industry.
• Expert in international GMP regulations (FDA, EMA, ICH).

Responsibilities

• Serve as primary Quality Single Point of Contact for CMOs/CLOs.
• Ensure cGMP compliance and oversee quality agreements.

Skills

Pharmaceutical Quality Control

GMP Regulations

Project Management

Cross-Functional Stakeholder Management

Analytical Skills

Education

B.A. or B.S. in Life Sciences

Tools

MS Office (Excel, PowerPoint, Word, MS Project)

Job description

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.

As an individual contributor in Pharma Technical Quality (PTQ), you will apply your extensive experience in pharmaceutical manufacturing and quality control to ensure the delivery of high-quality products and operational excellence. Driven by a passion for quality, continuous improvement and excellence in execution, you will act as the primary Single Point of Contact (SPoC) for designated Contract Manufacturing Organizations (CMOs) and will leverage these external partnerships to maximize global network capability while providing comprehensive Quality and Compliance oversight to reliably deliver products to patients.

The Opportunity:

• Serve patients through external partnerships as the primary Quality Single Point of Contact (SPoC) for designated Contract Manufacturing Organizations (CMOs) and Contract Lab Organizations (CLOs), managing the relationship throughout their lifecycle.

• Provide comprehensive Quality and Compliance oversight for Roche products at CMOs/CLOs, ensuring cGMP compliance across all activities, including technical transfer, validation, and ongoing manufacturing, packaging and testing.

• Apply your profound QC expertise you will lead related investigations, managing discrepancies, technical changes, CAPAs arising from CMO/CLO activities and ensure timely closure

• Oversee Make Assess Release (MAR) activities and maintain Quality Agreements with CMOs

• Author, review, and approve manufacturing and QC technical documents from contract organizations, such as batch records, protocols, reports, deviations, and Annual Product Quality Reviews.

• Provide scientific and technical support to Health Authority (HA) regulatory submissions and responses to HA information requests, potentially interacting directly with HAs on specific topics.

• Support the stability testing program at CMOs, including approval of protocols, reports, and related change requests, and manage critical reagents/reference standard supplies and forecasting for contract organizations.

• Oversee and coordinate the implementation of global Roche QC initiatives at contract organizations.

Who you are

• You hold a B.A. or B.S. degree in life sciences or a related scientific discipline.

• You possess sound knowledge of pharmaceutical Quality Control analytics and control systems.

• You have 5-7 years of progressive experience in the biopharmaceutical or related industry, or an equivalent combination of education and experience.

• You are an expert in international GMP regulations, including USA (FDA), EU (EMA; MHRA), and ICH Guidelines.

• You are experienced in managing quality and GMP compliance issues.

• You are proficient in cross-functional stakeholder management and have strong project management skills including team leadership, consultative facilitation, conflict resolution, and planning multiple concurrent projects.

• You are highly competent in MS Office applications (Excel, PowerPoint, Word, MS Project), fluent in oral and written English, and preferably experienced with contract manufacturing organizations.

Travel:

• 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 is an Equal Opportunity Employer.