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
External Manufacturing QA
Regulatory Compliance
Quality Systems Development
Risk Management
Nice-to-have
Innovative Thinking
Cross-cultural Environments
Agility to Drive Change
Team Collaboration Skills
Open Collaborative 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