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Roche is seeking a Global Fleet Program Owner responsible for overseeing the implementation of standardized systems across its manufacturing network. The ideal candidate will possess extensive experience in the pharmaceutical or biotech industry, with a strong focus on system standardization and compliance in a multi-site environment.
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Job Summary
The role serves as the single point of accountability for Drug Substance and Drug Product fleet equipment standards across multiple global sites.
Candidates must possess deep expertise in managing complex equipment throughout its entire lifecycle while ensuring strict GMP compliance.
The position requires leading impact analysis for changes to ensure consistent implementation across all affected systems while maintaining regulatory compliance.
Matching Summary
Match Score: 75
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Roche is seeking a Global Fleet Program Owner responsible for overseeing the implementation of standardized systems across its manufacturing network. The ideal candidate will possess extensive experience in the pharmaceutical or biotech industry, with a strong focus on system standardization and compliance in a multi-site environment.
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Skills & Requirements
Must-have
Master's degree in Engineering or Life Sciences
10 years pharmaceutical industry experience
GMP and ICH Q10/Q12 regulatory expertise
Multi-site equipment lifecycle management
Cross-site equivalency approval authority
Nice-to-have
PhD in related technical field
Strategic leadership and change management
Excellent communication skills
High degree of technical integrity
Ability to drive alignment across locations
Key Requirements
Minimum 10 years experience in pharma/biotech
Master's degree in Engineering or Life Sciences
Deep knowledge of Quality Systems (PQS)
Proven track record in cross-site impact assessments