Quality Assurance Manager and Quality Single Point of Contact (Small and La

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The 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.
IMP Quality Operations Switzerland is responsible delivering Investigational Medicinal Products (“IMPs”) to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and Compliance oversight of all. Our purpose is to create a purpose driven quality community that delivers innovative medicines to patients inline with GMP requirements.

The roles of this position are:

• Quality Assurance (QA) Manager for Investigational Medicinal Products (IMP). The focus is on the quality oversight of Drug Substance (DS) in Pharma Technical Quality (PTQ).
• Quality Single Point of Contact (QSPOC) for IMPs until PivGo is a strategic role working cross-functionally for the assigned molecules and partners with the TDT and IMPQ LT to implement a product quality strategy.

This position within IMP Quality Operations Switzerland requests a high level of flexibility, ability to work under pressure and sense of responsibility. You are inspiring, self-reflected and creative on the one hand and clear in communication as well as integrative in solution processes on the other. You have detailed knowledge of GMPs as well good interpersonal, managerial and negotiating skills and if you additionally like to follow a clear rational in decision making you should apply for this job.

The roles of this position are:

• Quality Assurance (QA) Manager for Investigational Medicinal Products (IMP). The focus is on the quality oversight of Drug Substance (DS) in Pharma Technical Quality (PTQ).
• Quality Single Point of Contact (QSPOC) for IMPs until PivGo is a strategic role working cross-functionally for the assigned molecules and partners with the TDT and IMPQ LT to implement a product quality strategy

The role of IMP QA Manager is assigned as a delegate of the Swiss Responsible Person for IMPs in Basel and

• responsible for the lot disposition of IMP bulk drug substance materials
• ensures that the quality of the produced IMPs, manufactured by Technical Research and Development (TR&D) Basel, is in accordance with cGMP regulations
• actively participates in compiling, reviewing and approving of Roche Pharma Quality System (PQS) standards
• reviews and approves documents, e.g. Production Records, change control documents, risk assessments, deviations
• participates in internal as well as in external audit

In the role of QSPOC you

• act as a single point of contact for the Technical Development Teams for Early State Products
• lead the Quality Sub Team consisting of all IMP relevant QA functions
• are responsible to identify and communicate significant quality risks as well as to drive risk mitigation pla