Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes at external manufacturers
Job Summary
Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes at external manufacturers.
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 at external manufacturers.
Skills & Requirements
Must-have
Small molecule drug substance manufacturing
External manufacturing quality oversight
Regulatory compliance and audits
Quality systems development and execution
Risk management and issue resolution
Nice-to-have
Innovative thinking and learning
Cross-cultural collaboration
Agility and adaptability
Strategic business alignment
Coaching and team development
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