Senior Specialist, Operation, Qa For Manufacturing
Zse68
Gmp compliance and quality oversight
Aseptic processing and contamination control
Quality documentation review and approval
The role involves ensuring that cell therapy products are manufactured according to approved procedures and comply with current GMP requirements
Job Summary
The role involves ensuring that cell therapy products are manufactured according to approved procedures and comply with current GMP requirements.
The position leads and influences quality professionals to ensure consistent application of quality systems and participates in continuous improvement initiatives.
The candidate will support internal audits, CAPA development, quality risk assessments, and maintain key performance indicators to safeguard patient safety and product quality.
Matching Summary
The role involves ensuring that cell therapy products are manufactured according to approved procedures and comply with current GMP requirements.
Skills & Requirements
Must-have
GMP compliance and quality oversight
Aseptic processing and contamination control
Quality documentation review and approval
Risk-based decision making
Quality system audits and CAPA implementation
Batch record and deviation investigations
Use of MES/eBR and QMS platforms
Nice-to-have
Project management skills
Continuous improvement mindset
Collaboration and ownership
Inspection-ready environment experience
Protocol and report authoring
Key Requirements
Bachelor’s degree in pharmacy, Life Sciences, or Biotechnology
5+ years GMP experience in cell therapy or biologics manufacturing
Experience with autologous or allogeneic workflows preferred
Familiarity with CFDA GMP, EU GMP Annex 1, PIC/S, US FDA CGMP
Knowledge of ICH Q7/Q8/Q9/Q10 and GAMP 5 standards
Preferred PMP, Lean Six Sigma, or GAMP certifications