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Johnson & Johnson is seeking a Manager External Quality in EMEA to oversee quality assurance for small molecule drug substances at external manufacturers. The role involves ensuring compliance with regulations, managing quality systems, and collaborating with internal and external teams to drive continuous improvement in manufacturing processes.
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Job Summary
Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation.
The role provides leadership and ensures success of external manufacturer qualification and monitoring with emphasis on continuous improvement, global alignment, and supply chain reliability.
The position requires frequent on-site presence at external manufacturers and collaboration with internal and external partners to maintain quality systems and regulatory compliance.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking a Manager External Quality in EMEA to oversee quality assurance for small molecule drug substances at external manufacturers. The role involves ensuring compliance with regulations, managing quality systems, and collaborating with internal and external teams to drive continuous improvement in manufacturing processes.
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Skills & Requirements
Must-have
Small molecule drug substance manufacturing
External manufacturer quality management
cGMP compliance support
Quality system development
Regulatory inspection management
Risk management in quality
Quality event and issue management
Nice-to-have
Strategic thinking capabilities
Coaching and team collaboration skills
Process excellence tools usage
Cross-cultural environment experience
Innovative thinking and learning environment
Strong interpersonal communication
Project management skills
Key Requirements
Bachelor's degree in Science or related field
6-9 years pharmaceutical cGMP experience
Experience with small molecule drug substance synthesis and quality
Experience in external manufacturing and technology transfers