Technical Manager-Global Annual Product Quality Review (APQR)
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 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, appropriate actions for product quality issues.
The Opportunity:
- You will conduct an annual single-site, cross-site, and End to End (E2E) reviews to deliver site and E2E APQR reports per requirements in GSP037.
- You will support the compilation of APQR reports via the acquisition and visualization 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**
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.