The role requires owning the end-to-end supplier lifecycle under GMP, including qualification, audits, and decommissioning for CMOs and material suppliers
Job Summary
The role requires owning the end-to-end supplier lifecycle under GMP, including qualification, audits, and decommissioning for CMOs and material suppliers.
Candidates must develop and negotiate Quality Assurance Agreements to ensure compliance with global regulatory standards like FDA, EU cGMP, and NMPA.
The position involves leading continuous improvement initiatives and influencing other quality professionals to ensure consistent application of key quality systems.
Matching Summary
The role requires owning the end-to-end supplier lifecycle under GMP, including qualification, audits, and decommissioning for CMOs and material suppliers.
Skills & Requirements
Must-have
7+ years QA manufacturing experience
GMP supplier lifecycle management
CMO oversight and audit execution
Risk-based decision making skills
Aseptic process and contamination control knowledge
Nice-to-have
Cell Therapy or ATMP experience preferred
MNC background experience
Veeva QMS system proficiency
ASQ quality certifications
Strong cross-functional collaboration
Key Requirements
Bachelor's degree in Pharmaceutical, Chemical, Biology, or related field
Minimum 7 years of QA/QC/manufacturing experience in GMP environment
At least 2 years focused on material/supplier quality or external manufacturing oversight
Experience with biological products preferred
Fluency in English for global communication and documentation