The PositionThe 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-[redacted] 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.
