Quality & Compliance – GxP Inspector – Roche – Basel, BS

Roche

At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

In Roche’s Pharmaceutical Research and Early Development organisation (pRED) , we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed. This position is located in Business Excellence, a chapter within the PS function, where process management is a primary focus. We closely collaborate with our therapeutic areas and functions to convert hypotheses into innovative therapeutics.

pRED’s Pharmaceutical Sciences (PS) group enables discovery and development of safe and effective therapeutics at optimal doses in relevant populations with a vision to power translation, continuously improve the accuracy of our predictions and accelerate the development of tomorrow’s medicines. PS supports discovery and development across the whole value chain from target assessment to on-market.

This position is located in the Enabling Sciences chapter within PS, which is accountable for overseeing the outsourcing strategy across PS to external partners (CROs, academic institutions etc.) and which acts as the single point of contact within PS for CRO oversight. The group works in close collaboration with PS scientific experts and Roche- internal groups (eg Procurement, Legal) to enable and optimize execution of internal and external resourcing strategies.

This position is located in the Enabling Sciences chapter, which is accountable for Quality & Compliance within Pharmaceutical Sciences. Quality & Compliance identifies and minimizes GLP and GCP compliance risks and deficiencies early through inspecting activities and training to protect the interests of Roche and the safety and wellbeing of patients/subjects/animals in Roche studies performed internally or externally.

Job mission

The Quality & Compliance group is the central contact for all quality-related topics in Pharmaceutical Sciences. The group maintains and continuously improves the existing quality system and has responsibility to assure compliance with GLP for non-clinical safety studies conducted internally by the Roche GLP Test Facility in Basel/Switzerland. It also provides quality oversight for analysis of clinical samples in Pharmaceutical Sciences` internal laboratories to assure compliance with applicable sections of GCP.

In addition, the Quality & Compliance group enables qualification of Pharmaceutical Sciences external partners (CROs, suppliers) for the conduct of GLP studies and for the analysis of clinical samples.

Your impact

  • Maintain and improve quality systems to ensure compliance to GLP, GCP and other applicable regulations across PS globally

  • Actively identify and develop and/or support the implementation of new concepts, tools, processes to improve the quality and best practices within PS

  • Conduct and provide oversight for GxP compliance auditing program to fulfill regulatory requirements

  • Manage and provide quality oversight for GxP QA operations through oversight of external vendors including implementation of corrective actions

  • Develop strategies to address quality and compliance solutions for emerging topics, e.g. digitalization, digital pathology, cloud storage

Your profile

  • At least five years of working experience in GxP (GLP or GCP) regulated environment

  • Detailed knowledge of a broad range of GLP and GCP regulations (OECD, FDA, Switzerland)

  • Demonstrated ability to assess risk and develop solutions for risk mitigation

  • Good understanding of toxicological studies, analytical methods (including biological assays) and animal welfare concepts

  • Profound understanding in computer system lifecycle methodologies (CSV, periodic and audit trail review)

  • Proven auditing and communication skills in English

  • You build a culture of trust around you and are comfortable working with a wide array of stakeholders

  • Command of German language (understanding)

  • Role model the following mindsets and behaviors:

    • I am accountable

    • I act on behalf of the whole company, not just my team.

    • I have a growth mindset

Your location

Basel

You’re someone who wants to influence your own development. You are looking for a company where you receive the opportunity to pursue your interests across functions and geographies. Working in a multi-cultural environment motivates you.

Are you ready to apply? We want someone who thinks beyond the job offered – someone who knows that this position can be a rare springboard to many other opportunities at Roche.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Level:

Individual contributor

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