Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes
Job Summary
Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes.
Ensures proactive and continuous compliance with applicable Health Authority regulations and J&J standards, including effective risk management.
Leads frequent interactions with external manufacturers, up to and including Sr. Management levels, for the purpose of driving reliability, continuous improvement, Risk management, Quality strategies and Quality System compliance.
Matching Summary
Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes.
Skills & Requirements
Must-have
small molecule drug substance manufacturing
external manufacturer quality oversight
cGMP compliance
Health Authority regulations
risk management
quality systems development
Nice-to-have
innovative thinking and learning
coaching skills
collaborative leadership style
strategic thinking capabilities
balanced decision-maker
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