Senior Legal Counsel, Global TechOps & Pharma Quality

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

Join Roche, where every voice matters.

Great medicine cannot change the world if it never leaves the lab. As Senior Legal Counsel - Global Tech Ops & Pharma Quality, you will step onto a highly collaborative, global team providing proactive legal support to our Pharma Technical Operations (PT) organization. In this high-impact role, you will advise on complex, high-stakes matters to ensure our medicines are manufactured and delivered safely to patients worldwide while supporting our mission to prevent, stop, and cure diseases.

In this role, you will be at the forefront of global technical operations and quality compliance, driving legal excellence through key responsibilities:

• Lead Strategic Legal Counseling:
  Partner directly with the PT Global Head of Quality and PT Global Head of Regulatory to provide legal risk guidance on critical quality governance, change control, and cGMP compliance.
• Advise on Global Regulatory & Compliance Matters:
  Guide commercial operations and technical teams on EMA, FDA, Swiss medic, and other global health authority manufacturing compliance requirements.
• Support Inspections and Audits:
  Provide strategic legal direction during health authority facility inspections and internal GMP audits to protect product integrity and prevent enforcement actions worldwide.
• Manage Critical Quality Events:
  Collaborate closely with the Quality organization to resolve supply interruptions, manufacturing deviations, health authority notifications, and field actions.
• Drive External Quality Partnering:
  Structure novel quality agreements and align compliance standards with external CMO and CDMO networks to ensure seamless external manufacturing oversight.
• Direct Outside Counsel:
  Oversee and manage external legal counsel retained to support specialized technical operations and regulatory matters.

We are looking for a proactive, solutions-oriented legal expert who thrives in a fast-paced global environment and brings:

• Legal
  
  Qualifications:
  
  Qualified attorney-at-law (e.g., Rechtsanwalt, avocat, or equivalent) in at least one European jurisdiction.
• cGMP & Manufacturing Expertise: 7+ years of experience with cGMP and manufacturing support in a pharmaceutical/biotech corporate setting, top-tier law firm, or relevant regulatory agency.
• Cross-Cultural Leadership & Acumen:
  Strong business acumen, excellent interpersonal skills, and the ability to influence and drive positive change across multinational teams.
• Technical Communication
  
  Skills:
  
  Proven capability to clearly translate complex, highly technical information into actionable legal advice in written and spoken English (proficiency in German, French, or Dutch is a plus).
• Agile & Collaborative Mindset: A results-oriented mindset, constructive approach to challenging the status quo, willingness to travel, and commitment to driving legal excellence.

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.