Gary Lynch Email & Phone Number

Along with my staff, I have the opportunity to provide technical and strategic leadership for validation, risk management, and CAD services for the North American manufacturing plants. By partnering with Division-level colleagues and the various site leadership teams, it is my privilege increase our manufacturing capacities and help bring new products to market. In leading technical exchanges with global validation leadership teams, I strive to share best practices across our sites, leverage our collective knowledge, and introduce some exciting quality and operational improvements. Fun!In prior roles, I have had the privilege to successfully lead Quality Assurance and Engineering Departments. I ensured site compliance with changing regulations and standards and supported manufacturing operations for medicines and medical devices I helped bring through clinical trials. Finding innovative methods to bring new products to market safely, quickly and cost-effectively is a passion of mine. Some tools that help ensure success are: - Create risk-based qualification/validation practices- Partner with others to establish clear, consistent and compliant operations- Establish practical and effective training programs- Implement clear policies, procedures and helpful templates- Identify meaningful metrics to inform changes that allow right-first-time rates to soar!There are two common threads to my work over the years: (1) Striving to make complex processes easy to understand; and (2) Developing metrics-gathering systems that enable our business units to target areas for improvement. Achievements:- Lilly 'Changing the World' Award and 'Global Solution Achievement' Award- Created metrics program that led to stunning improvements in right-first-time results- Launched QA audit programs and led highly successful audit teams of suppliers and in-house operations- Appointed to lead QA effort to outsource facility management services- Selected to consult on CT material packaging outsourcing evaluation and contract awards- Ensured successful Pre-Approval Inspection for a new medical device manufacturing facility- ISPE Speaker on Risk-Based Validation- Corporate Trainer for Risk-Based Computer System Validation, Peer Reviews and Subcontractor Management- IPQC Speaker on Commissioning and Qualification; FDA Audit Preparation; and Calibration Systems- Ensured operations comply with 21 CFR Parts 11, 110, 211, and 820; and ISO 13485

Listed skills include Gxp, Quality Management, Pharmaceutical Industry, Regulatory Affairs, and 39 others.