Minimum four years pharmaceutical operations experience
At least two years quality experience in product release
Experience with aseptic sterile biological drug manufacturing
This role provides quality oversight of Contract Manufacturing Organizations to ensure compliance with Bristol Myers Squibb standards and international regulatory requirements
Job Summary
This role provides quality oversight of Contract Manufacturing Organizations to ensure compliance with Bristol Myers Squibb standards and international regulatory requirements.
The position involves authoring disposition documentation, managing Annual Product Reviews, and supporting inspection readiness for new products transferred to CMOs.
Bristol Myers Squibb offers a wide variety of competitive benefits and programs designed to support employee goals both at work and in personal lives.
Matching Summary
This role provides quality oversight of Contract Manufacturing Organizations to ensure compliance with Bristol Myers Squibb standards and international regulatory requirements.
Skills & Requirements
Must-have
Minimum four years pharmaceutical operations experience
At least two years Quality experience in product release
Experience with aseptic sterile biological drug manufacturing
Contract manufacturing or contract testing background
Proficiency with SAP and Quality Management Systems
Nice-to-have
Knowledge of combination products manufacturing
German language proficiency
Experience with analytical method protocols
Strong negotiation skills without authority
Ability to adapt rapidly to changing environments
Key Requirements
Minimum B.S. degree in relevant scientific discipline
Four years experience in pharmaceutical operations
Two years experience in Quality functions
Experience with GMP tools and standard applications