George Lapole

Benchling is a GxP compliance SaaS company that specializes in supporting pharmaceutical and biotechnology companies in organizing, preparing and executing research and development activities. The software is validated and follows Annex 11 while the QMS follows ISO9001 with consideration to customer regulatory requirements. • Quality Systems process owner and SME for Change Management, Deviation/CAPA Management, Document Control, Records Management, Compliant Management and Training Management. • Improved processes for Training, Change Management and CAPA Management to bring systems into compliance while improving efficiency and reducing process times by up to 3 days. • Authored, reviewed and approved GxP documents and records for various business processes within the QMS to include Engineering, Product Management, Customer Support and GxP Compliance. • Supported Audit Management by providing regulatory guidance to the Audit Manager communicating expectations and best practices for internal audits and external customer audits. • Established and reported on Quality Metrics for Change Management, Training, Document Control and CAPA Management. • Presented training on GxP principals, best practices and expectations as it relates to business and customer expectations.

Bio-Rad is a global top 5 industry leader which provides new instrument technology, software, consumables, reagents and other products for life science research, clinical diagnostics and digital biology markets. BioRad has numerous QMS’s to support the business at different levels of regulatory requirements and standards; our team was responsible for GMP efforts within 6 plants which were governed under two separate QMS’s. • Responsible for the quality oversight and compliance of GMP manufacturing across 6 plants. • Led and empowered a team of 10+ quality professionals to support the daily operations performed to ensure timely release and shipment of product while upholding the Quality Policy. • Led team to drive nonconformance and deviation management to ensure investigations identify root cause and to initiate appropriate corrective and/or preventive actions, escalating as appropriate. • Led team to host customer audits, conduct vendor audit and support regulatory inspections. • Provided Quality review and approval on GMP controlled documents and records relating to or supporting GMP manufacturing, product development, continuous improvement, stability studies and validation activities. • Provided oversight and approval on product development teams, working closely with Regulatory Affairs, to ensure activities and deliverables met compliance requirements and were inspection ready.

IRRAS is a Class II commercial stage medical device which manages intercranial pressure and CSF drainage. While there, IRRAS was submitting for their 510(k) clearance and obtaining a CE mark for EU sales and distribution. They have since obtained these goals. • Responsible for the quality oversight and compliance of the GMP activities and deliverables from contract manufacturing (CM) sites for a class IIb medical device. • Routinely audited CM Device Master Record (DMR) while maintaining an internal shadow file to ensure completeness and alignment to maintain inspection readiness. • Provided Quality review and approval on GMP documentation and records relating to nonconformance, new product development and design changes, assembly and release of product both internally and at the CM. • Led validation program to ensure proper qualification of CM’s assembly lines, work instructions, tools, equipment, critical suppliers, material release, product testing and final release. • Led continuous improvement efforts to streamline assembly work instructions and update release testing to align with real-life scenarios. • Managed computer systems validation program to onboard new software and maintain compliance of existing systems. • Managed internal and supplier CAPA, nonconformances and deviation management to ensure proper investigations identified root cause and appropriate corrective and/or preventive actions were carried out.

Bachem is a global leader in developing and manufacturing peptides and oligonucleotides for pharmaceutical and biotech companies. • Supervised a team of quality professionals to support the daily operational activities of GMP manufacturing, such as batch review, clearances, floor audits, material management to release and ship product (drug substance) to customers. • Led Material Review Board to manage CAPAs, nonconformances and deviations to ensure proper investigations identified root cause and appropriate corrective and/or preventive actions were carried out. • Acted as SME and quality representative to support cross functional initiatives, customer meetings and internal audits. Provided back-room support for external audits and regulatory inspections.

Pacira is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving patient outcomes. Their cornerstone product is Exparel, a long lasting pain management drug which is inject into the site. • Performed internal audits to identify process gaps and drive continuous improvement initiatives. • Performed supplier qualification audits for raw materials and services to approve for use and add to approved supplier list. • Supported inspection readiness by maintaining inspection playbook, training teams on inspection conduct and providing back-room support during on-site visits. • Led continuous improvement projects for quality, such as developing instruction tutorials on using vials for customers, establishing a global product recall program and moving to electronic documentation by implementing a validated eDMS. • Supported complaint management by investigating failures, managing corrective actions and providing written responses to customers. • Provided quality review and approval of controlled documents, such as SOPs, test methods, specifications, validation records and marketing material.