Sean Blake Email & Phone Number

Baltimore, Md, Us

Oversees the global IT function, including IT strategy; information security; DevOps; global Quality Assurance; and end user support.As Chief Information Security Officer responsible for planning, implementing, and maintaining an enterprise information security strategy to protect the security and integrity of Company and customer environments. Recently attained ISO 27001 certification.

Durham, North Carolina, Us

Durham, Nc, Us

Oversaw the global IT function, including IT strategy; information security; infrastructure and architecture; scientific computing; application integrations and development; business process re-engineering; outsourcing; and end user support. Assessed the impact of emerging technology to strategic business needs, served as a member of the leadership team, and influenced strategic business decisions regarding the use of technology. As Chief Information Security Officer responsible for planning, implementing, and maintaining an enterprise information security strategy to protect the security and integrity of Company systems. Recently attained ISO 27001 certification.As Data Privacy Officer ensures compliance with all relevant US and International data privacy regulations.

Durham, Nc, Us

Directed strategic planning, budget management, execution, and oversight for all Information Services department functions in support of short- and long-term business goals. Drove compliance of systems and environment with FDA, Sarbanes-Oxley, and FISMA regulations. Established and deployed policies and procedures to build secure, reliable, and effective technology environment. Initiated, developed, and managed relationships with third party vendors, including direct management of outsourced IT support and administrative services provider.• Led migration of essential services to cloud, resulting in greater data availability and reliability while reducing operating expenses by 15%.• Devised and implemented solutions and procedures to support compliance with federal government regulations (FDA, FISMA, and 21 CFR Part 11), to include computer system validation program, qualified server environment to simplify server, and validated application management and maintenance.• Expanded technology resources in Birmingham, Alabama Research and Development facility, improving customer service and efficiency by reducing incident response time and equipment downtime.• Wrote and administered information security and training program.• Streamlined operating procedures of outsourced service provider to enhance customer experience and shorten incident resolution times.• Provided IT security services to outsourced vendor, to include Computer System Validation consulting and testing, IT audits, risk assessments, gap analysis against frameworks such as 800-53 and 800-171, pre-sales, project scoping, and policy and procedure writing.

Durham, Nc, Us

Guided enterprise-wide information technology initiatives and services, developing departmental goals and objectives aligned with organizational strategic plan. Oversaw 26 team members providing IT support to 4,200 employees in 60 countries. Consulted with Business Unit Directors to architect international technology environment supporting revenue-driving strategies. Managed multiple budgets and work plans. Mentored, trained, developed, and supervised staff to meet career development and customer satisfaction goals.• Designed and implemented new standardized Country Office technology platform in collaboration with Business Unit leaders, enhancing technical capabilities and producing significant cost savings, including $700,000 for Nigerian office alone.• Built International Operations Support team, improving enterprise-wide collaboration, technology utilization, ROI, service delivery, and support of IT projects.• Created Regional IT Support Group, bolstering customer service delivery and expediting problem resolution for FHI 360 offices in Africa and Asia.• Negotiated with international ISP to secure standardized services and support to locations in Asia and Africa at reduced cost.• Evaluated Country Office IT operations and instituted improvements to processes and procedures, optimizing workflow, bolstering local operational support, and strengthening relationships between Headquarters and Country Offices.• Restructured Service Desk teams in Washington, DC and Durham, NC, developed unified problem resolution philosophy and process, and implemented Service Catalog and Service Level Agreements, accelerating problem resolution and improving results of customer satisfaction surveys.

Santa Barbara, Ca, Us

Responsible for the planning, delivery and overall management of SharePoint Server 2010 implementations for life science companies. Duties included:Manage project plans and deliverables to ensure projects are completed on time and on budget.Provide validation expertise to ensure implemented solutions meets regulatory requirements such as 21 CFR Part 11. This included writing project documentation such as Standard Operating Procedures and Qualification tests.Perform installation and troubleshooting tasks in support on project implementation.

Led strategic planning and implementation of all information systems and technology for home office and remote employees while driving compliance with Sarbanes-Oxley and FDA regulations. Directed staff members, planned and administered budget, selected and managed vendors, defined business requirements, and oversaw project planning and deliverables. Provided technical consultation and guidance to Commercial Operations, Marketing, Finance, Technical Operations, and Quality Assurance groups to support successful product launches.• Collaborated with executive leadership to select and implement validated technology solutions for Quality Control, BioStatistics, and Regulatory departments.• Established Steering Committee comprised of senior management to drive IT strategies aligned with business goals.• Secured resources, capabilities, and approval from CFO to grow IT department, shaping the role and value of the department through high-impact deliverables.• Wrote and instituted Information Technology policies and procedures to ensure compliance with Sarbanes-Oxley and FDA regulations as well as improve department performance.• Conducted numerous cGxP vendor audits to support operations of Quality Assurance and Clinical departments.

Focused on strategic planning, implementation, and administration of all information systems and technology, building facilities management, and laboratory instrument maintenance. Lead application development and infrastructure staff members, managed budget, selected and oversaw vendors, defined business requirements, and produced deliverables through formal project plans. Managed annual budget of 3 million dollars and equipment assets in excess of 8.5 million dollars.Accomplishments:Collaborated with research leaders to identify and prioritize projects necessary for implementation of high throughput screening processes. Lead successful implementation of mission critical projects.Maintained infrastructure (server, database, and network) availability in excess of 99.99%, while reducing operating costs by 30%. Led design and implementation of IT architecture in support of scientific and business applications. Member of Senior Management team responsible for developing and implementing policies that effect day to day operations of company.Designed and implemented the company's computerization from the ground floor; led the installation and integration of a state-of-the-art and highly secure network. Developed and implemented disaster recovery and archiving procedures.Led development and implementation of IT security policies and standards.Led development and implementation of hardware and software change control process.Hired and developed initial infrastructure staff.

Provided day-to-day leadership and direction of the information technology department for a cGMP biopharmaceutical manufacturing company. Managed budget in excess of 8 million dollars. Accomplishments:Led multimillion dollar project to identify and select work flow and document management systems.Member of Covance Infrastructure Management and Global IT Leadership Teams. Achieved 100% network and server availability for mission critical ERP system.Implemented SOPs, and infrastructure changes to ensure cGMP and FDA compliance.

Provided day-to-day leadership and direction to team responsible for the design, development and management of information technology infrastructure. Managed budget in excess of 3 million dollars.Accomplishments:Championed and led projects that required an investment over $2 million dollars in hardware and software. These projects directly resulted in achieving infrastructure availability of greater than 99.999%.Led data center migration project. Completed ahead of schedule with no user downtime. Hired and developed initial infrastructure support team of 7 team members.

Indianapolis, Indiana, Us

Information Systems Managed Servers (ISMS)Led and developed Operations team responsible for more than 90 file and print servers, 1300 print queues, and 10,000 users. Managed hardware and software budget in excess of 1 million dollars.Accomplishments:Led project to implement user and file server security standards. Assisted in development of user and file server security standards.Led project that implemented performance monitoring and hardware failure notification on over 90 servers.Identified and selected alternate hardware vendor which saved company over $60,000 in first six months.

Bs, Information Systems Management

Masters Certificate, Advanced Information Assurance And Security