Jennifer Sparrow Email & Phone Number

New Jersey, United States

Partnered with Global Information Services on the IT transformation program to decommission and sunset old technology and implement cloud-based Product Lifecycle Management (PLM) and Quality Systems across the entire organization, globally.

Global Quality and Compliance representative for the Strategic Exploration, Due Diligence and Transition, as Johnson and Johnson explored strategic options for the Ortho business and subsequently divested the business unit. Lead the entire transformation of the QMS from divestiture to stand alone Ortho while maintaining a compliant profile worldwide.

Managed all aspects of Ortho Quality and Compliance. Ensured robust implementation and sustainability of the QMS. Maintained positive compliance profile and metrics.

Directed complaint handling and global vigilance reporting for multiple product lines. Reported risks to Senior Management and implemented improvements for on-time vigilance reporting. Hosted multiple Health Authority and certification audits successfully.

Managed Operating Company compliance risk through FDA readiness activities, application of global quality systems, and facilitating communication of outstanding issues. Responsible for Ethicon and Ethicon-Endo Surgery, both maintained successful regulatory position. Supported Lifescan and Depuy with inspection readiness and complaint vigilance assessments.

Specialized in Quality and Compliance consulting for Medical Device, Pharmaceutical, Diagnostics and Biologic industries. Remediated Consent Decrees, Warning Letters and implemented compliance turn-around projects. Provided Strategic input to Executive Management on risks and QMS recommendations.

Led and maintained site compliance to FDA and ISO Regulations through audits of all Operations, R&D and Quality elements, including Design History Files and Design Control requirements.

Fully implemented the QMS and validation program for this novel product. Hosted all pre-market audits and attained successful FDA approval for first home HIV test kit. Trained all staff in GMP.

New Jersey District

Progressive growth and positions of increasing responsibility; including Lead Investigator, Trainer, and assignments as Compliance Officer, Supervisory Investigator and Device Pre-Approval Coordinator