This role performs QC laboratory shop floor quality oversight to ensure product testing complies with approved procedures and GMP requirements
Job Summary
This role performs QC laboratory shop floor quality oversight to ensure product testing complies with approved procedures and GMP requirements.
The position leads and influences quality professionals to ensure consistent application of key quality systems and participates in continuous improvement initiatives.
Candidates will support internal audits, CAPA implementation, quality risk assessments, and participate in project teams to maintain regulatory compliance.
Matching Summary
This role performs QC laboratory shop floor quality oversight to ensure product testing complies with approved procedures and GMP requirements.
Skills & Requirements
Must-have
GMP laboratory quality oversight
QA review and approval of GMP documentation
Quality system implementation and monitoring
Analytical method transfer and validation
Regulatory compliance with CFDA, EU GMP, US FDA
Experience with MES/eBR and QMS platforms
On-site work and off-hours support
Nice-to-have
Leadership and influence across quality teams
Continuous improvement mindset
Project management skills
Risk-based decision making
Collaboration in high-stakes environments
Key Requirements
Bachelor’s degree in pharmacy or related field
5+ years GMP cell therapy or biologics experience
Experience with autologous or allogeneic workflows
Familiarity with CFDA GMP, EU GMP Annex 1, US FDA CGMP
PMP, Lean Six Sigma, or GAMP certifications preferred