Head of MSAT Qualification & Validation
On-site · Shanghai, Shanghai, China
Job Summary
Head of MSAT Qualification & Validation leads the Qualification & Validation (Q&V) functions at Roche, directing a high-performing team to design, execute, and continuously improve qualification and validation activities for the facility, equipment, and processes. Responsibilities include driving IOPQ, APS, and process/cleaning validation for seamless technology transfer, developing and implementing qualification strategies, ensuring cGMP compliance, and leading cross-functional collaboration with Engineering, Quality, Manufacturing, and site leadership. The role emphasizes strategic partnership, risk-based decision-making, and a culture of continuous improvement, with focus on aseptic manufacturing readiness, operational excellence, and QA/Regulatory readiness. The position requires substantial MSAT expertise, strong leadership, and the ability to translate high-level strategies into actionable plans while guiding teams through audits, CAPAs, and process optimization initiatives.
Required Qualifications
- Bachelor’s Degree (Pharmaceutical / Biological is preferred)
- Over 10 years of MSAT experience in the injection pharmaceutical industry, with MNC Bio-pharma preferred
- At least 5 years of hands-on experience in Qualification and Validation
- Minimum of 5 years in people management experience with a proven track record of leading and developing teams
- Extensive experience in strategic projects for aseptic filling facilities including design, commissioning & qualification
- Strong knowledge of cGMP regulations applicable to pharmaceutical/biological industry
- Fluent English communication skills; ability to effectively collaborate with global teams
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