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The Position

As a GMP Compliance Specialist in the GMP Support & Compliance team of Operations Support & Compliance (PTDC-T), you serve as a key contact and partner to analytical development unit PTDA, providing expertise and support for GMP compliance in analytical development and QC processes. This role is crucial in enabling smooth operations for PTDA and aligning business requirements with those of several partners and stakeholders.

The Opportunity

In this role, you will work in “Synthetic Molecules Technical Development” (PTDC). PTDC brings a broad range of experience across drug substance (DS), drug product (DP), and analytical sciences. We collaborate closely with key partners in research and early development, as well as our commercial counterparts. PTDC is responsible for the technical development of our synthetic molecule pipeline and for manufacturing drug substances and products for clinical studies.

 

You manage, coordinate and facilitate local GMP compliance processes such as quality risk management, deviations, CAPA and changes.

You act as an expert and first-level support for quality systems and their business processes (e.g., Cornerstone, Veeva OneQMS, QualityDocs, QRM) incl. training of SME’s

You are accountable for the management of access to GMP relevant areas and account management for GMP systems

You oversee inspection management for internal audits and health authority inspections within PTDC and PTDA

Driving optimization and standardization of GMP-related processes and the existing document landscape in close alignment with key stakeholders

You collaborate with team members in a role-based working environment, and you build and grow relationships with customers and partners across functional boundaries

Who you are:

You have a Bachelor’s or equivalent and/or higher degree in chemistry or pharmaceutical sciences or operational experience in a GMP environment within the pharmaceutical industry

You have experience in synthetic & large molecule manufacturing and quality control is a plus

You are fluent in German and have good verbal and written communication skills in English

You enjoy working flexibly in an experienced team and appreciate undertaking diverse and varied activities 

You are curious about the team's work plate and priorities and offer help when needed

You appreciate being empowered to make decisions in your field of expertise and actively seek feedback from others

Location: Basel

GG: SE 5

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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 life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.