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.
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.
The Opportunity
Oversee quality and compliance for external GxP suppliers and outsourced products to ensure they meet cGMP and Quality Agreement standards. These suppliers include CDMOs, CLOs, CROs, CWO, partners, and others.
Serve as the Quality Point of Contact (PoC) for designated suppliers/products, participating in cross-functional management teams for supplier selection, management, and decommissioning.
Provide quality expertise and compliance assessments during in-licensing and M&A due diligence events.
Represent Quality as the Single Point of Contact (Q-SPOC) for early-stage programs and act as a Delegate of the Swiss Responsible Person when assigned.
- Oversee quality activities throughout the lifecycle of GxP suppliers (Source & Select, Implement, Manage, Decommission) including process/method validations, audits, inspections, investigations, complaints, and regulatory submissions. Develop and maintain Quality Agreements and ensure compliance
- Work with GxP suppliers to improve audit responsiveness, CAPA implementation, deviation management, complaint resolution, investigation closure, and change implementation. Escalate issues as needed
- Manage quality activities for Make Assess Release (MAR) including approval of process documentation, batch reviews, investigation resolutions, change assessments, and monitoring supplier performance. Release, reject, or quarantine Roche products based on compliance requirements
- Maintain manufacturing processes, Specifications and Analytical Methods (SAM), stability testing programs, and oversee quality of direct material changes and certifications. Develop and implement quality risk management plans to mitigate supplier risks
- Manage quality deliverables for manufacturing, testing, packaging, and product launches at external sites. Engage in supplier improvement initiatives and resolve complex quality issues, ensuring alignment with Roche objectives
- Notify Senior Management of quality or regulatory issues, foster effective partnerships, approve relevant documents, and comply with Roche Code of Conduct. Communicate updates on regulatory requirements to suppliers and complete job-related training requirements
- Lead and support continuous improvement initiatives, mentor colleagues, and deputize for the GxP Supplier Management Chapter Lead when needed. Perform additional quality-related activities to ensure compliance and drive quality improvements
Who you are
- Holds a B.A. or B.S. degree in life sciences or equivalent, with experience in the pharmaceutical or related industry. Experience with GxP suppliers such as CMO, CLO, and direct material suppliers is a plus
- Possesses sound knowledge of cGMP, ISO standards, and international pharmaceutical regulations. Capable of interpreting quality standards as they relate to GxP suppliers
- Highly competent in MS Office or Google Suite applications including Excel, PowerPoint, Word, and MS Project. Operational Excellence expertise is also considered a plus
- Ability to communicate clearly and professionally both in writing and verbally. Fluency in oral and written English is essential, with additional language skills being a plus
- This position may require up to 10% domestic and/or international travel
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.
