Technical Manager, Quality Process Management - APQR

F. Hoffmann-La Roche AG; Mississauga; Hybrid; CAD 89,000 - 117,000; Full time

Job summary

A Roche em Mississauga está contratando um Gerente Técnico, Qualidade de Processos APQR, para liderar a revisão anual de APQR e manter padrões de controle de qualidade ao longo do ciclo de vida dos produtos. O papel envolve colaboração com equipes multifuncionais e a gestão de dados para identificar tendências e ações corretivas.

É necessário formação em Life Science (B.A./B.S. ou superior) e 3–5 anos de experiência em ambientes CGMP, com foco em produtos químicos ou biológicos.

Qualifications

• Formação mínima em Life Science exigida.
• 3–5 anos de experiência em cgmp farmacêutica ou biotecnológica.
• Capacidade de liderar equipes transversais e influenciar sem autoridade formal.
• Conhecimento de APQR e processos de qualidade de produto.

Responsibilities

• Conduzir avaliações anuais APQR de site e end-to-end.
• Apoiar a compilação de relatórios APQR a partir de dados de sites Roche.
• Identificar e escalar questões de qualidade do produto e propor ações.
• Apoiar o desenvolvimento, manutenção e execução de sistemas APQR globais.

Skills

Cross-functional leadership

Data analysis

APQR/process improvement

Education

B.A./B.S. or higher in Life Science

Tools

Enterprise databases

Analytics tools

Collaboration platforms

Job description

## Technical Manager, Quality Process Management - APQRCandidatar-se: Mississauga: Tempo integral: Publicado hoje: Data de término: 11 de setembro de 2026 (1 dia restante para se candidatar): 202609-123007At 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, escalate, 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.