MSAT Qualification & Validation Senior Manager

Principle Roles & Responsibilities / Accountabilities

Leadership & People Management

• Exhibit exceptional leadership aligned with the VACC model, demonstrating a capacity to craft and execute forward-thinking strategies. Cultivate a high-impact environment by systematically eliminating barriers, advancing both people and technical capabilities, and enabling individuals to perform at their peak potential.

• Lead and develop a high-performing team, with a strong emphasis on people development, fostering individual growth, and enhancing collective skillsets to meet evolving organizational needs. Champion team building and cohesion to create a collaborative environment where shared success is prioritized.

• Serve as an unwavering advocate for Roche's mission of advancing and boldly championing diversity, equity, and inclusion, shaping an organizational ethos that reflects these pillars in all initiatives.

• Forge and sustain strategic alliances with site leaders to ensure alignment on high-priority initiatives, drive synergy across cross-functional operations, and achieve mutually advantageous relationships that deliver enduring organizational success.

• Oversee the implementation and continuous evolution of site SHE procedures, embedding best-in-class programs to surpass corporate/site SHE KPIs. Lead cultural transformation by embedding SHE principles into the organizational DNA and fostering a proactive employee safety mindset.

• Inspire, mentor, and direct the organization, while driving performance excellence and advancing team members’ development toward achieving both organizational objectives and their personal and professional aspirations.

• Build a strong pipeline of talent and robust succession plans for key positions.

• Spearhead a culture of relentless continuous improvement by embodying and advocating lean leadership principles, driving operational excellence that aligns with global benchmarks.

• Instill a transparent, innovation-driven, and high-performance culture built on empowerment, ownership, and bold thinking, ensuring the organization sustains a competitive edge in a dynamic market environment.

• Acts as a mentor and coach to less experienced colleagues, providing guidance in mastering complex Q&V workflows, troubleshooting technical challenges, and developing skills in MSAT operations.

Technical

Engineering Project Support and Operation Readiness:

• Actively contribute to the design and construction of the new facility, encompassing key activities such as IOPQ, APS, and process/cleaning validation for seamless technology transfer, ensuring successful project execution and delivery.

• Lead and develop a high-performing qualification and validation team, fostering a culture of innovation, technical rigor, and cross-functional collaboration.

• Act as a technical Subject Matter Expert (SME) and people leader, guiding team members in qualification, process and cleaning validation, manufacturing support and troubleshooting to drive operational excellence.

• Collaborate with MSAT leadership to align qualification and validation strategies with site and global technical roadmaps, ensuring seamless integration and strategic consistency.

Routine Operation:

• Qualification and Validation: Lead Qualification and Validation team and also serve as a SME in qualification and validation, be accountable to develop, deploy and optimize business processes for the qualification/validation of equipment, utility systems, and facilities, maintaining the qualification program in a cGMP state of compliance. Be accountable to develop, deploy and optimize business processes for shipping system qualification/validation, maintaining the qualification program in a cGMP state of compliance. Support to lead efforts to optimize processes for aseptic manufacturing, maximizing cost efficiency, and ensuring scalability, robustness, and operational excellence. Drive continuous process improvements by implementing innovative solutions and advanced technologies, enhance equipment performance through effective root cause analysis and troubleshooting.

• Technical Support & Continuous Improvement: Provide real-time qualification and validation guidance during project running, manufacturing campaigns, resolving deviations, and implementing CAPAs. Collaborate cross-functionally (Engineering, Quality and Manufacturing) to troubleshoot issues, drive root-cause analysis, and enhance process robustness, yield, and quality via >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.