/ Hiring

Principal Technical Manager, Device Design Control

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

The incumbent in this position willbe responsible for managing Device Development Quality areas includingdevelopment of Design Controls and associated documentation, documentationcontrol system implementation, as well as coordinating educational forums for projectteams. Quality System areas of accountability include Risk Management, DesignHistory Files, and other aspects of Design Controls. With respect to DesignControls, responsibilities include participation in cross-functional initiativesto develop, influence and globally align the Design Control strategy whileensuring consistent practices are adopted and followed. The incumbent will alsoserve as the primary liaison / spokesperson between Quality and the DeviceDevelopment Leadership team. He/she will work with Device Teams to create,oversee maintenance and continuously improve Design Control processes forteams, and drive consistency in approach and documentation content across thepipeline portfolio to streamline development. Regular interaction with DeviceTeam Leaders is required. The position requires working with teams to developand implement Risk Management plans and Design History Files ensure theapproach is consistently applied across projects. The incumbent will supportinternal and external audits of the department, and is accountable for ensuringthat the department is in compliance with regulatory requirements forcombination products. The incumbent will regularly interface with thosefunctions contributing to execution of the Device Strategy including but notlimited to Clinical, Development, Manufacturing Collaborations, Quality andRegulatory Affairs.  The incumbent willalso support the continuous improvement of business processes related tocombination product development and commercialization, providing linkagesbetween the Design Controls and device business processes. The incumbent willalso serve as a departmental representative for commenting on global regulatoryauthority draft guidance and proposed rules.

 

Who You Are

• B.S. degree in Life Sciences or equivalent
• At least 10 years’ experience in the Pharmaceutical orMedical Device industry, with at least 3-5 years of experience in devices orcombination products
• Extensive knowledge of global quality system / regulatoryrequirements for devices
• Working knowledge of manufacturing, quality, and regulatoryareas pertaining to delivery devices and combination products
• Working in a highly matrixed environment
• Excellent interpersonal, communication, and influencingskills

The next step is yours. To apply today, click on the "Apply online" button below.

Genentech is an Equal Opportunity Employer.