Quality oversight of contract manufacturing organizations
Cgmp and international regulatory standards
Product disposition activities
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Bristol Myers Squibb is seeking a Manager of Quality Operations in Boudry, Switzerland, to oversee quality assurance for Contract Manufacturing Organizations (CMOs). The role emphasizes compliance with Good Manufacturing Practices (GMP) and requires significant experience in pharmaceutical operations, quality management, and technical writing.
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Job Summary
This quality manager provides quality oversight of Contract Manufacturing Organizations (CMOs), supporting management of CMO disposition documentation and Annual Product Review.
Responsibilities include performing product disposition activities, authoring disposition documentation, reviewing disposition documents from CMOs, and ensuring batch documentation is maintained.
The role requires strong negotiation, communication, and presentation skills, with demonstrated technical expertise in deviation resolution and CAPA.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Manager of Quality Operations in Boudry, Switzerland, to oversee quality assurance for Contract Manufacturing Organizations (CMOs). The role emphasizes compliance with Good Manufacturing Practices (GMP) and requires significant experience in pharmaceutical operations, quality management, and technical writing.
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Skills & Requirements
Must-have
Quality oversight of Contract Manufacturing Organizations
cGMP and international regulatory standards
Product disposition activities
Annual Product Quality Reviews
Quality Agreements with external manufacturers
Nice-to-have
Balance business implications and quality decisions
Negotiation and influencing without authority
Rapid adaptation to changing environment
Support for new projects and technical transfers
Key Requirements
Minimum 4 years in pharmaceutical operations
Minimum 2 years in Quality
Experience in aseptic, sterile, and biological drug product manufacturing
Experience in contract manufacturing or contract testing