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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.

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.

The Opportunity

In his role you will be responsible for:

• Managing, coordinating and facilitating local GMP compliance processes as quality risk management, deviations, CAPA and changes.

• Acting 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

• Management of access to GMP relevant areas and account management for GMP systems

• Inspection management for internal audits and health authority inspections within PTD

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

• Collaborating with team members in a role-based working environment, as well as building and growing relationships with customers and partners across functional boundaries

Who you are

• You have a Bachelor’s degree or higher (or equivalent) in Chemistry, Pharmaceutical Sciences, or solid operational experience in a GMP environment within the pharmaceutical industry

• You bring experience in synthetic and/or large molecule manufacturing and quality control (a strong advantage)

• You enjoy working flexibly in an experienced team and thrive in a collaborative environment

• You are curious about the team’s priorities and workload, and proactively offer support where needed

• You are empowered to make decisions in your area of expertise and take ownership of your work

• You actively seek feedback and use it to learn, grow, and continuously improve

• You have excellent language skills, fluent in German with good written and verbal communication in English

Are you interested to make an impact? Please apply by submitting your updated CV and cover letter via our careers portal.

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.