Technical Manager-Global Annual Product Quality Review (APQR)

Roche; Mississauga; On-site; CAD 90,000 - 120,000; Full time

Job summary

A leading company is seeking a Technical Manager for the Global Annual Product Quality Review (APQR). This role involves conducting reviews, compiling reports, and ensuring product quality across Roche's network. The ideal candidate will have a degree in Life Science and experience in the pharmaceutical industry, with strong leadership and technical skills.

Qualifications

• 3-5 years of applicable cGMP pharmaceutical or biopharmaceutical industry experience.
• Ability to lead cross-functional teams and resolve complex technical issues.

Responsibilities

• Conduct annual APQR reviews and deliver reports per GSP037 requirements.
• Support APQR stakeholders in identifying and resolving product quality issues.

Skills

Leadership

Problem Solving

Technical Expertise

Education

B.A., B.S., or higher degree in Life Science

Tools

Enterprise Databases

Collaboration Tools

Analytics IT Platforms

Job description

Technical Manager-Global Annual Product Quality Review (APQR)

Join to apply for the Technical Manager-Global Annual Product Quality Review (APQR) role at Roche.

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

• 12 Month Contract 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.

The Technical Manager, Global Annual Product Quality Review (APQR) supports and drives the APQR process per GSP037 “Annual Product Quality Review (APQR)” for Roche commercial products. The goal is to identify trends and issues affecting product control and manufacturing processes throughout their lifecycle, and to propose necessary actions for product quality issues.

The Opportunity

1. Conduct annual single-site, cross-site, and End to End (E2E) reviews to deliver site and E2E APQR reports per GSP037 requirements.
2. Support the compilation of APQR reports by acquiring and visualizing data from sites across the Roche network.
3. Work with APQR stakeholders to identify, escalate, and resolve product quality issues, proposing APQR action items as needed.
4. Support the development, maintenance, and execution of Global APQR systems, projects, and administrative activities.
5. Support APQR and Quality oversight activities, ensuring cross-functional team deliverables are completed in a compliant, accurate, high-quality, and timely manner.

Who you are

1. You will have a B.A., B.S., or higher degree (preferably in Life Science) with 3-5 years of applicable cGMP pharmaceutical or biopharmaceutical industry experience, or an equivalent combination of education and experience.
2. You bring the ability to lead cross-functional teams, resolve complex technical, quality, and business process issues, and influence without formal authority.
3. You have technical expertise in small and large molecule drug substance and drug product manufacturing processes, including knowledge of medical devices and device combination products.
4. Experience with enterprise databases, collaboration tools, and analytics (IT platforms), including routine metrics reporting, is preferred.
5. Relocation benefits are not eligible for this position.

Who we are

A healthier future drives us to innovate. Over 100,000 employees worldwide are dedicated to advancing science and ensuring access to healthcare. Our efforts have treated more than 26 million people and conducted over 30 billion tests with our Diagnostics products. We foster creativity, explore new possibilities, and aim to deliver life-changing healthcare solutions.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.