MSAT Qualification Lead

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

• Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward -thinking outlook; remove barriers,
• Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion.
• Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
• Contribute to a culture of continuous improvement and model lean leadership principles
• Contribute to a culture of transparent, high performance, empowerment and innovation culture.
• Acts as a mentor and coach to less experienced colleagues, providing guidance in mastering complex validation workflows, troubleshooting technical challenges, and developing skills in MSAT operations.

Technical

Engineering Project Support and Site Start Up Readiness:

• Participate in the design and construction of new facilities, including but not limited to manufacturing/cleaning process design, URS review, FAT, SAT, IOPQ, tech transfer and other aspects related to MSAT activities, thereby contributing to project delivery.
• Accountable for analysis of end-to end production process and facility capabilities to identify opportunities for improvement.
• Provides assessment of site capabilities with respect to new or modified processes
• Assesses product quality impact and root cause for significant process related investigations
• Maintain Process Validation and Cleaning validation status according to requirement of GSP, network SOP, and regulatory

Technical Expertise & Routine Operation:

• Serve as a Subject Matter Expert (SME) of process and/or cleaning validation: Develop and establish appropriate validation methods and validation plans. Lead initiate process and/or cleaning validation, re-validation, and periodic cleaning validation reviews.
• Implement process validation including creating protocol, sampling plan, training and report.
• 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.
• Troubleshoot and resolve issues encountered during validation processes.
• Optimize cleaning to minimize contamination risks and enhance operational flexibility.
• Drive continuous improvement initiatives for SUT processes, with a focus on waste reduction, cycle time optimization, and sustainability.
• Support process equipment qualification as needed.
• Ensure all process and/or cleaning validation activities comply with GMP and relevant regulatory requirements.
• Participate in audits and regulatory inspections, providing expert knowledge and documentation on validation processes.
• Maintain a strong knowledge of regulations, especially those related to process and/or cleaning validation, equipment qualification.
• Work closely with internal teams and external stakeholders to facilitate smooth execution of validation projects.
• Provide training and guidance on validation best practices to team members and stakeholders.
• Other tasks assigned by the manager.

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

• 5 or more years process and/or cleaning validation experience, 8 or more years MSAT/Technical or qualification and validation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
• People management experience is a plus
• Prior experience in qualification and validation is advantageous
• Correlative Knowledge of validation
• Demonstrated experience in strategic thinking; highly skilled in negotiations, collaboration, and influencing
• Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification
• Experienced in new facility startup readiness and operation ramp
• Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
• Strong business acumen, communications, and analytical thinking required
• Strong interpersonal, leadership, collaboration and conflict resolution skills
• Experience leading major change initiatives strongly preferred
• Project management skills and Leading team capability preferred
• Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
• Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
• Knowledge of Quality management

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.