Technical Manager-Global Annual Product Quality Review (APQR)

F. Hoffmann-La Roche Gruppe; Mississauga; On-site; CAD 80,000 - 100,000; Full time

Job summary

Join a leading healthcare company as a Technical Manager for Global Annual Product Quality Review. In this role, you'll oversee quality processes, conduct reviews, and collaborate with cross-functional teams to enhance product quality. Your expertise in life sciences and experience in the pharmaceutical industry will drive innovation and ensure compliance in product quality management. This position offers a unique opportunity to contribute to healthcare advancements while working in a supportive and inclusive environment.

Qualifications

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

Responsibilities

• Conduct annual reviews to deliver APQR reports.
• Support compilation of APQR reports through data acquisition.
• Work with stakeholders to resolve product quality issues.

Skills

Leadership

Technical Expertise

Problem Solving

Education

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

Tools

Enterprise Databases

Collaboration Platforms

Analytics

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

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. This role involves identifying trends and issues affecting the overall control of products and their manufacturing processes throughout their lifecycle, and implementing appropriate actions for 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 requirements in GSP037.
2. Support the compilation of APQR reports through data acquisition and visualization from sites across the Roche network.
3. Work with APQR stakeholders to identify, escalate, and resolve product quality issues, and propose APQR action items as needed.
4. Support the development, maintenance, and execution of Global APQR systems, projects, and administrative activities.
5. Ensure cross-functional team deliverables are completed in a compliant, accurate, high-quality, and timely manner, supporting APQR and Quality oversight activities.

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 will have the ability to lead cross-functional teams, resolve complex technical, quality, and business process-related issues, and influence without formal authority.
3. You possess technical expertise in small and large molecule drug substance and drug product manufacturing processes, including knowledge of medical devices and device combination products.
4. You have experience with enterprise databases, collaboration platforms, analytics, and routine metrics reporting processes.

Relocation benefits are not eligible for this position.

Who we are

More than 100,000 employees worldwide are dedicated to advancing science and ensuring access to healthcare. Our efforts have resulted in over 26 million treatments and 30 billion tests using our diagnostics. We foster creativity, explore new possibilities, and aim to deliver healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.