Joseph C.
Director of Gmp Quality Assurance @Mineralys Therapeutics, Inc.
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WORK HISTORY
Director of Gmp Quality Assurance @Mineralys Therapeutics, Inc.
Draft, review, approve, and maintain Standard Operating Procedures. • Review batch records and release and disposition of drug substance and drug product batches. • Function as the key contact for all GMP quality matters for Mineralys-sponsored clinical trials. • Manage investigations and documentation of out-of-specification results, deviations, and product complaints. • Manage auditing program to meet regulatory requirements by performing audits, mock inspections reporting findings, and ensuring findings are effectively investigated and closed out. • Ensure compliance with any applicable regulations including FDA, ICH, GxP, and internal policies and procedures. • Support the SVP Quality Assurance by hosting regulatory inspections. • Manage monthly/quarterly reports submitted to senior management to ensure visibility of QMS requirements and performance including the compilation of quality metrics to facilitate monitoring and management of the Quality System. • Attends and represents Mineralys Quality for GMP service Providers. • Oversee GMP audits conducted by third parties. • Assist with validation and management of GxP Quality Systems Requirements
EDUCATION
University of Delaware
Project Management Certificate, Project Management
Saint Joseph's University
Master of Business Administration - MBA, Pharmaceutical Marketing and Management
The Center for Professional Innovation and Education, Inc.
(BDCP) Biopharmaceutical Development Certified Professional, Pharmaceutical Sciences
ABOUT JOSEPH C.
Experienced Quality Assurance Manager with a demonstrated history of working in the…
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