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Roche is seeking a Manager of Quality and Digitalization Quality in Shanghai, China, focusing on overseeing qualification and validation processes within the pharmaceutical industry. The role involves ensuring compliance with GxP regulations and supporting the rollout of digital systems in GxP areas.
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Job Summary
This role is responsible for the quality oversight of all qualification and validation activities within PT China to ensure compliance with global standards and GxP regulations.
The position requires leading Data Integrity assurance efforts, including maturity assessments and embedding DI principles into routine GxP activities.
Roche offers a culture that encourages personal expression and genuine connections, allowing employees to thrive while working on life-changing healthcare solutions.
Matching Summary
Match Score: 75
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Roche is seeking a Manager of Quality and Digitalization Quality in Shanghai, China, focusing on overseeing qualification and validation processes within the pharmaceutical industry. The role involves ensuring compliance with GxP regulations and supporting the rollout of digital systems in GxP areas.
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Skills & Requirements
Must-have
7+ years pharmaceutical industry experience
3+ years GMP facility experience
Expertise in equipment and process validation
Computerized system validation (CSV) knowledge
Data Integrity (DI) management and assessment
GxP regulatory compliance expertise
Nice-to-have
Experience with solid or aseptic processing
Project management skills for global initiatives
Strong English communication abilities
Leadership in cross-functional squads
Super user experience with SAP or MES
Key Requirements
Bachelor's degree in Pharmacy, Chemistry, or related field
Minimum 7 years work experience in pharmaceutical industry
Minimum 3 years experience in commercially licensed GMP facility