Mony Clark

Mony Clark has a diverse work experience in the field of quality assurance and compliance. They started their career as a Research Assistant at Cengent Therapeutics, where they gained experience in protein crystallization and data entry. They then moved to MicroConstants, Inc. as a QA Validation Specialist, where they wrote technical reports and analyzed pharmacokinetic data. At NextPharma, they served as a Senior QA Aseptic Specialist, responsible for writing variance reports and approving manufacturing line clearances.

Following this, Mony joined Teleflex Incorporated as a QA/QC Supervisor, where they supervised and trained QC Technicians and executed internal audits. They then worked at Invivoscribe as a Senior QA Specialist, re-structuring the CAPA, Nonconformance Material Reporting, and Deviation Systems. They later became a Quality Assurance Manager at Invivoscribe, taking on additional responsibilities such as managing quality systems and overseeing QA staff.

Mony then joined Gilead Sciences as a Consultant, Inspection and Supplier Management, where they led gap analysis and risk assessment associated with regulatory findings and managed inspection activities for New Drug Application submission. At Bayer, they worked as a Quality Compliance, Internal Audit Manager, managing the internal audit program and identifying compliance and safety risks.

Currently, Mony works at GenMark Diagnostics as the Director of QA, overseeing QA activities and leading the implementation of quality and compliance transition activities.

Throughout their career, Mony has demonstrated strong leadership skills, including managing and developing teams, establishing goals and objectives, and guiding and mentoring staff. They have also shown expertise in managing quality systems, leading audits, and implementing process improvements.

Mony Clark has a Bachelor of Science (B.S.) degree in Biochemistry and Cell Biology from UC San Diego. Mony also holds a Master of Science (MS) degree in Regulatory Affairs from San Diego State University. In addition to their degrees, Mony Clark has obtained certifications as an ASQ Certified Quality Auditor and Quality Engineer from ASQ in December 2012.