Technical Manager, Quality Process Management - APQR (Mississauga)

Technical Manager, Quality Process Management - APQR (Mississauga)

06 Sep
|
Roche
|
Mississauga

06 Sep

Roche

Mississauga

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. 12 Month Contract Position 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. 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, escape, 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 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; 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. We use artificial intelligence to screen, assess or select applicants for this role. 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 recent possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Roche is an Equal Opportunity Employer. #

📌 Technical Manager, Quality Process Management - APQR (Mississauga)
🏢 Roche
📍 Mississauga

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