Michael is a recognized quality professional whose expertise in quality systems spans medical device, pharmaceutical, gene therapy and biologics industries.  His experience includes multiple senior management positions in organizations from startups to Fortune 100 organizations including contract manufacturers.

Michael has been instrumental in:

• Creating, evaluating, revising quality systems elevating them toward best in class performance
• Leading culture change for life sciences creating an organizational culture of compliance
• Overseeing new product development activities for medical device, pharmaceutical and biologics organizations
• Managing the assessment process to deliver high performing GXP systems for development and manufacture of consumer, biologics, gene therapy, medical device and pharmaceutical products
• Leading organizations through multiple FDA regulatory audits as well as DEA and notified body audits.
• Implementing risk based strategies and capabilities for development and manufacturing of pharmaceutical, medical device, biologics and supplement products.
• Directing corporate compliance activities for manufacturers of pharmaceuticals, medical devices, gene therapies and biologics.
• Developing multi-year quality and compliance strategic plans.

Michael is currently leading the development of strategies, solutions and tools for life science organizations to successfully manage risk and deliver high quality products to patients.