The ideal candidate will have strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams to support clinical manufacturing and regulatory compliance requirements. Create, revise, and manage controlled documents (SOPs, protocols, forms, etc.) within the electronic document management system (EDMS). Issue, review, and close batch production records to ensure completeness, accuracy, and compliance with GMP standards. Manage and investigate deviations, ensuring thorough root cause analysis, corrective actions, and timely closure. Support the assessment and implementation of change controls, ensuring proper documentation and impact analysis. Ensure compliance with GMP, FDA, FACT, and other regulatory standards. Support internal and external audits, including preparation, execution, and follow-up on audit findings. Oversee the review of controlled documents, deviations, CAPAs, and other quality records to ensure timely completion.

Operates and maintains a strategic research compliance program and ensures University adherence to all research compliance policies. Monitors compliance laws and regulations and updates University policies to adequately reflect new revisions. Supports all University members on research matters compliance and oversees research compliance trainings. Mitigates research compliance risks, coordinates and facilitates the Institutional Biosafety Committee (IBC) operations, shares research compliance expertise, and serves as the University's compliance expert.

Operates and maintains a strategic research compliance program and ensures University adherence to all research compliance policies. Monitors compliance laws and regulations and updates University policies to adequately reflect new revisions. Supports all University members on research matters compliance and oversees research compliance trainings. Mitigates research compliance risks, coordinates and facilitates the Institutional Biosafety Committee (IBC) operations, shares research compliance expertise, and serves as the University's compliance expert.

The ideal candidate will have strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams to support clinical manufacturing and regulatory compliance requirements. Create, revise, and manage controlled documents (SOPs, protocols, forms, etc.) within the electronic document management system (EDMS). Issue, review, and close batch production records to ensure completeness, accuracy, and compliance with GMP standards. Manage and investigate deviations, ensuring thorough root cause analysis, corrective actions, and timely closure. Support the assessment and implementation of change controls, ensuring proper documentation and impact analysis. Ensure compliance with GMP, FDA, FACT, and other regulatory standards. Support internal and external audits, including preparation, execution, and follow-up on audit findings. Oversee the review of controlled documents, deviations, CAPAs, and other quality records to ensure timely completion.