Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes at external manufacturers in the EMEA region
Job Summary
Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes at external manufacturers in the EMEA region.
Ensures proactive and continuous compliance with applicable Health Authority regulations and J&J standards, including effective risk management and inspection readiness.
Responsible and accountable for the quality and reliability of products produced at external manufacturers, coordinating and executing management activities.
Matching Summary
Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes at external manufacturers in the EMEA region.
Skills & Requirements
Must-have
Small molecule drug substance manufacturing
External manufacturing quality oversight
Regulatory compliance and audits
Quality system development and execution
Risk management and issue resolution
Nice-to-have
Innovative thinking and learning
Cross-cultural collaboration
Agility and adaptability
Strategic business alignment
Open and interactive leadership
Key Requirements
Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry/Technical/Synthesis Process technology/Chemical Engineering
6-9 years' experience in Pharmaceutical cGMP environment
Experience in External Manufacturing, Technology Transfers, Quality Event Management
Ability to manage Quality Systems and provide cGMP compliance support