Greg Blasko Email & Phone Number

Boston, Ma, Us

• Lead Quality Standard implementations for Computerized Systems and Data Integrity ensuring Vertex’s global QMS is integrated, sustainable, scalable, compliant, fit for purpose and efficient to meet emerging and future business needs across modalities (small molecule, cell & gene, device, combination products), acquisitions, future disease areas, GxP areas, and geographies• Establish and lead a cross-functional process owner governance body to provide oversight of the Computerized Systems and Data Integrity Quality Systems for process improvements, regulatory surveillance, training enhancement, inspection readiness & response, and metrics review • Serve as the strategic Quality Lead for an integrated clinical and commercial platform providing optimal orchestration across the entire value chain between Vertex, health care organizations, contract manufacturing organizations, and logistics providers by providing quality oversight of computerized system lifecycle activities and data integrity, leadership, and project management support• Ensure the compliance of digital enablement strategies and enterprise applications to support regulatory filings, inspection readiness, and commercial launches of gene-editing based autologous therapies

Cambridge, Cambridgeshire, Gb

• As a trusted advisor, collaborate closely with Research, Product Development, and Quality Control senior management to provide subject matter expertise and thought leadership towards the global design and delivery of innovative laboratory computing capabilities for GLP and GMP laboratories• Lead a $1.7 million project to modernize Alexion’s laboratory computing architecture and upgrade R&D instrument computers to Windows 10, providing a best-in-class environment meeting industry standards for data integrity, compliance, cybersecurity, and supportability• Manage laboratory system associates, conduct performance reviews, set objectives, coach and mentor, review training and career development plans, maintain a strong and motivated team• Possess a deep understanding of computer system validation (CSV), regulatory compliance including FDA 21 CFR Part 11/Annex 11, GAMP 5, change management, event (deviation/CAPA) management, and associated quality management systems supporting GxP enterprise scientific platforms and laboratory instrumentation• Accountable for all technology supporting laboratory instrumentation globally including asset management, incident response, change management, service catalog fulfillment, and demand management utilizing the ITIL framework and ServiceNow ITSM platform• Work closely with outsourced managed service providers delivering application, system, and infrastructure support to multiple business units; ensure services fulfill customer and internal IT service levels

Boston, Massachusetts, Us

• Collaborated with cross-functional IT teams to implement a networking architecture and data strategy for R&D and Q/C laboratories in Cambridge Massachusetts, Bogart Georgia, and Paris France• Led all risk mitigation efforts for laboratory relocations to a new world headquarters in New Haven, Connecticut; Ensured the successful move of over 200 instrument computer systems• Developed policies and procedures regarding laboratory system lifecycle management from acquisition through decommissioning and provided expertise on new lab instrumentation purchases• Managed global instrumentation and cross-departmental application support for all laboratory computers including validated systems with 21 CFR Part 11 requirements

New Haven, Ct, Us

• Lead the design, development, implementation, and communication of policies and practices for Workstation and Technology Services, a unit within Library Information Technology• Managed a team of technicians responsible for the reliability and security of a large computing infrastructure of over 850 endpoints through hardware, network, security, and specialty application support• Maintained an annual device lifecycle and backup budget; Collaborated with Yale IT Services on University-wide strategic goals including the adoption of the ITIL framework and ServiceNow ITSM platform

New Haven, Ct, Us

• Played a critical business partnering role in the design and construction of a $9.2 million biotechnology laboratory encompassing over 25,000 square feet; Oversaw the relocation of eight biotechnology laboratories • Managed all IT operations in the Keck Foundation Biotechnology Resource Laboratory; Supervised IT support specialists and developed employees through performance feedback, coaching, and mentoring • Supported 300 Windows and Mac workstations and 10 Windows servers; Implemented disaster recovery strategies securing mission critical administrative, laboratory and staff data