Technical Manager-Global Annual Product Quality Review (APQR)
Technical Manager-Global Annual Product Quality Review (APQR)
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1 Vacancy
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
** 12 Month Contract Position**
A healthier future. Its 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.
Thats 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 singlesite crosssite 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 crossfunctional 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 crossfunctional teams resolve complex technical quality and business processrelated 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 100000 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 lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Exec
Employment Type
Full-Time
