Technical Manager, Quality Process Management - APQR

Roche; Mississauga; On-site; CAD 89,000 - 117,000; Full time

Job summary

Roche in Mississauga, Canada is seeking a Technical Manager, Quality Process Management - APQR to lead and execute the APQR process for Roche commercial products, identify trends impacting the state of control, and propose suitable actions to protect product quality throughout the life cycle.

You will conduct annual single-site and end-to-end APQR reviews, compile reports from data across the Roche network, work with stakeholders to resolve quality issues, support Global APQR systems and ensure

Qualifications

• B.A., B.S. or higher in Life Science or related field.
• 3–5 years in cGMP pharma/biopharma or related industry.
• Ability to lead cross-functional teams and resolve complex quality/process issues.
• Experience with data extraction, visualization and reporting for APQR.

Responsibilities

• Lead annual site and end-to-end APQR reviews and reports as per REQ-0300212 and SOP028938.
• Compile APQR reports through data acquisition and analysis from Roche sites.
• Identify, escalate, and resolve product quality issues; propose APQR actions.
• Develop, maintain, and execute global APQR systems and projects.
• Support APQR and Quality oversight activities ensuring compliant, timely deliverables.

Skills

Cross-functional leadership

Data analysis

APQR process knowledge

Influencing without authority

Education

Bachelor’s degree (Life Science)

Tools

Enterprise databases

Analytics platforms

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.

The Technical Manager, Quality Process Management - APQR, supports and executes the APQR process per Annual Product Quality Review (APQR) Requirements and Annual Product Quality Review (APQR) Process for Roche commercial products to identify trends and issues that affect the overall state of control of products and their manufacturing process throughout their life cycle, and, if necessary, to describe appropriate actions for product quality issues.

The Opportunity:

• You will conducts annual single-site and E2E reviews to deliver site and E2E APQR reports per requirements in REQ-0300212 and sop028938
• You will support the compilation of APQR reports via the acquisition, visualization, and analysis of data from sites across the Roche network
• You will work with APQR stakeholders to identify, escal, and resolve product quality issues and Proposing APQR actions items, as needed
• You will support the development, maintenance, and execution of Global APQR systems, projects, and administrative activities
• You will support APQR and Quality oversight activities while ensuring cross-functional team deliverables are completed in a compliant, accurate, high quality and timely manner

Who you are:

• 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 or related industry, or an equivalent combination of education and experience
• You will bring the ability to lead cross-functional teams, resolve complex technical, quality, and business process-related issues; extract optimized business results through skillful collaboration and application of principles for influencing without formal authority
• Your technical expertise in small and large molecule drug substance and drug product manufacturing processes and associated control and documentation systems. Including knowledge of medical devices and device combination products is desirable
• Your experience with enterprise database, collaboration platform tools, and analytics (IT platforms) is preferred including experience in routine (business and/or compliance) metrics reporting processes is desirable
• Relocation benefits not eligible for this position* The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

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.