MSAT Qualification & Validation Senior Manager

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

Principle Roles & Responsibilities / Accountabilities主要职责/责任

Leadership & People Management领导与人员管理

• 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 技术

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 data-driven innovation. Ensure E2E processes consistently comply with cGMP requirements, Roche standards, and regulatory expectations from health authorities (NMPA, FDA, and EMA). Lead Q&V team focused audits and inspections, prepared comprehensive technical responses, and drove implementation of corrective and preventive actions.
• Strategic Partnerships & Thought Leadership: Represent Roche MSAT in external Q&V forums, conferences, and working groups to benchmark and integrate industry best practices. Collaborate with qualification vendors to co-develop innovative solutions aligned with Roche’s strategic priorities (e.g., closed systems).
• Identify the customers/stakeholders that are the recipient of the service delivered, including but not limited to global projects, global MSAT, Roche manufacturing network, PD China, RCPT internal customers, suppliers. Utilize tools such as CRM, SPOC to establish this understanding and document accordingly.
• Global Collaboration on Innovation: Partner with global teams to integrate cutting-edge technology into GMP manufacturing, facilitating seamless scale-up and execution. Contribute to innovation pipelines by participating in global technology forums and steering committees. Leverage insights from international collaborations to introduce advanced methodologies for process intensification, including novel bioreactor design, high-efficiency downstream processing systems, and process digitalization initiatives.
• Cross-Functional Project Leadership: Lead global, cross-functional projects by coordinating efforts between R&D, engineering, quality, and site operations teams. Ensure seamless integration of global requirements into local operations, driving shared ownership and accountability.
• Maintain Qualification and Validation status according to requirement of GSP, network SOP, and regulatory.
• Guide to implement process validation including creating protocol, sampling plan, training and report.
• Guide to implement cleaning validation including creating protocol, sampling plan, training and report. By supporting the recovery rate from coupon materials to ensure the accuracy of sampling and taking the chemical samples for cleaning validation.
• Maintain Qualification Master Plan, Validation Master Plan, Network and Local SOPs’ implementation.
• Involved in the main global network subject team, attend the network meeting regularly.

Qualification and Experience 能力与经验

Education/Qualifications

• Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above

 

Job Required Competencies 岗位所需胜任力 

• Over 10 years of MSAT experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
• At least 5 years of hands-on experience in Qualification and Validation
• A minimum of 5 years in people management experience, with a proven track record of leading and developing teams 
• Extensive experience in strategic project of Aseptic Filling facility including design, commissioning & qualification 
• Expertise in new facility startup readiness and operation ramp up including organization, people and operation management system
• Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry 
• Demonstrates strategic thinking with the ability to translate high-level strategies into actionable plans; proficient in leveraging agile methodologies to drive efficiency and adaptability
• Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.

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.