Switzerland Job Openings

Roche

Quality Assurance Manager and Quality Single Point of Contact (Small and Large Molecules) – IMP Quality Operations Switzerland

Basel

FULL TIME

October 20, 2024

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 c GMP. 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 Piv Go 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.

Your Opportunity:

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 c GMP 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 audits

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 plan

Who you are:

Master degree or Ph D in Life Sciences and minimum 5 years of relevant experience in the pharmaceutical industry
Demonstrated experience in a Pharmaceutical Technical Development environment, preferably in Small Molecules
Knowledge of c GMP and Quality requirements for clinical development stages
Strong leadership, communication and influencing skills
Ability to communicate clearly and professionally both verbally and in writing in English as well as in German

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

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