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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Accountable for all technology supporting laboratory instrumentation globally including asset management, incident response, change management, service catalog fulfillment, and demand management utilizing the ITIL.
• 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