MSAT Sterility Assurance 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.

Principle Roles & Responsibilities / Accountabilities主要职责/责任

Leadership

• Possesses strong creative leadership aligned with the VACC model, with a proven ability to foster innovation, shape forward-thinking perspectives, and overcome obstacles.

• Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion.

• Establish and sustain strong partnerships with site leaders to ensure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

• Enables a network of sterility assurance experts to directly or indirectly influence others to achieve results in a complex manufacturing and regulatory environment, potentially operating within global and cross-site models.

• Contribute to a culture of continuous improvement and model lean leadership principles.

• Foster a culture of transparency, high performance, empowerment and innovation.

Technical 

Engineering Project Support and Operation Readiness: 

• Provide technical expertise during facility qualification, cleanroom validation, and sterilization process validation, ensuring all contamination control measures are robust, scalable, and aligned with global regulatory requirements.

• Collaborate with engineering and manufacturing to implement advanced systems and technologies, such as isolators, rapid microbial techniques, and automation, to enhance sterility and operational efficiency.

Sterility Assurance Program Development

• Develop and execute Roche's sterility assurance strategy, integrating contamination control frameworks, risk management systems, and aseptic best practices for seamless technology transfer and successful site startup.

• Lead the design, validation, and oversight of sterility-related processes, including media fills, sterilization validation (e.g., VHP, steam, dry heat), cleanroom qualification, filtration processes, and aseptic processing controls.

• Optimize and implement comprehensive environmental monitoring (EM) and contamination control frameworks, ensuring compliance with cGMP standards during ramp-up and routine operations. 

• Conduct trend analysis on EM data and contamination incidents to identify improvement opportunities and ensure sustainable contamination control strategies.

• Serve as the site's primary SME in sterility assurance, providing expert guidance in aseptic manufacturing workflows, microbial risk management, environmental monitoring, filtration integrity testing, and container closure integrity (CCI) validation.

• Build trusted relationships with industry experts and stakeholders to advance Roche's sterility assurance capabilities and global influence.

• Build trusted relationships with internal stakeholders, industry experts, and external vendors to co-develop cutting-edge contamination control technologies and sterility management systems.

• Represent Roche in industry working groups, conferences, and forums to benchmark sterility assurance practices, assess emerging trends, and ensure alignment with global industry advancements.

Continuous Improvement & Innovation

• Drive sterility-focused continuous improvement initiatives, focusing on reducing contamination risks, enhancing sterility assurance programs, and ensuring consistency across production phases.

• Evaluate and integrate novel contamination control technologies, authoring technical assessments and gap analyses to align sterility strategies with emerging trends.

• Develop and manage sterility-specific risk management frameworks (e.g., FMEA) to ensure contamination risks, sterile hold times, and environmental excursions are effectively controlled.

• Proactively refine sterility assurance processes such as batch release parameters, EM trends, media fill criteria, and sterilization regimes, ensuring consistent compliance with quality standards.

Cross-Functional Collaboration and Global Alignment

• Partner with global and site technical teams to execute seamless technology transfers for aseptic-based processes into production environments.

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

• Represent Roche in global sterility assurance forums and cross-functional initiatives, ensuring manufacturing innovations are integrated with sterility standards.

Manufacturing Support & Compliance

• Author and review sterility assurance-related sections in technical documents, including media fill protocols, validation reports, risk assessments, and environmental monitoring SOPs, ensuring accuracy and adherence to regulatory expectations.

• Ensure aseptic processes comply with cGMP, Roche standards, and global health authority requirements (e.g., FDA, EMA, NMPA).

• Supervise the development and implementation of sterility validation reports, cleaning validation protocols, SOPs, and sterility test procedures to support both site startup and ongoing operations.

• Provide real-time technical guidance to production teams, addressing sterility-related challenges, including investigations into contamination events, root cause analysis, and effective implementation of corrective and preventive actions (CAPA).

• Serve as a key participant in regulatory audits and inspections, presenting sterility assurance evidence and addressing compliance-related queries from authorities.

Qualification and Experience 能力与经验

Education/Qualifications 教育背景/资格要求

• 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 Sterility Assurance

• 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.

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.