Patrick Gondek

Background

About Patrick Gondek

Proven Quality leader with a strong combination of quality system, product, on-market product quality support, program management skills, managing contract manufacturers (external manufacturers), while being customer focused. Experience in quality system remediation, regulatory inspection preparation and management, stage gate development projects and strategic program management. A history of successfully implementing change in challenging environments and successfully balancing competing priorities across a number of projects. More than 25 years experience in the pharmaceutical and medical device industry including over 20 years in Quality in various positions of increasing responsibility combined with an Engineering degree from a leading engineering school. • Created a new organization within US Commercial Quality to support the US Commercial Organization and US customers including trending customer specific complaint data, customer visits, acting as an advocate for Commercial and customers within the Quality organization, and quality oversight and support for US Field Sales, Marketing, Trade Sales, and Field Service Engineers. • Led initiative with support from external consultants to redefine an enterprise-wide Supplier and Third Party Manufacturing Quality programs which identified efficiencies and ensured compliance. • Experience managing on-market Quality issues and new product launch activities for injectible pharmaceuticals and medical devices. • Quality Lead for integration of strategic acquisitions and partnerships as well as divestitures. • Designed and implemented global quality system improvements including Risk Assessment, Management Review, CAPA/Investigation and Change Management for Third Party Manufacturing. Specialties: Managing Contract Manufacturers/Third Party Manufacturers (CMOs), Project Management, Cross-functional Teaming, Change Management, Process Improvement, Risk Assessment, Alliance Management, cGMP Auditing, Quality Agreement Negotiation, Supplier Quality, Post Market Surveillance, customer visits, field actions and recalls, field alerts