Matin Shaikh

Background

About Matin Shaikh

Matin has extensive experience in the design and delivery of high-performance digital operations solutions to address complex regulatory and business problems within Life Sciences, Medical Device and Biotechnology domain. Proven ability to develop thoughtful and robust client relationships to build strategic account footprint. Proven track record of overall practice management including strategic account growth, M&A strategy, recruiting and talent development. • Successfully led large engagement teams solving complex business and regulatory problems. Strong technology strategy background with a proven ability to create, build and retain highly energized and focused teams. • Served as a strategic and trusted advisor to various life sciences companies concerning compliance and validation of enterprise-level software cloud solutions including Adverse Event Management, Product Lifecycle Management, Document Management, Supply Chain / Manufacturing, Serialization and Quality Systems • Led functional and compliance efforts for complex system implementations of large scale ERP implementation such as Oracle, JD Edwards, and SAP S4 HANA • Extensive experience in assisting client with strategy development and implementation of cloud based solutions across multiple functions • Provided technical guidance concerning compliance methodology, managing global requirements, CAPA/NC and all aspects of the software development lifecycle including ITIL Specialties- Building strategic account footprints in Life Sciences, Medical Device and Biotech Industry - Large Program/Engagement Management including leading Pursuits and Pricing - Digital Quality and Risk Management - Quality by Design/ Cost of Quality Assessments - M&A Regulatory Due Diligence - Enterprise Cloud Risk Management - Quality Management Systems - Regulatory/Quality Business Process Transformation - FDA PreCert, SaMD Operating Model - Consent Decree Support - Oracle, JDE, SAP ERP, PLM and LIMS FDA Compliance