Jim Graffam Email & Phone Number

Mountain View, CA, US

Egnyte is a leading cloud content governance platform that empowers businesses to manage, secure, and unlock the full potential of their digital content by combining content security, compliance, and collaboration tools into a unified platform. Egnyte helps companies enhance productivity, ensure data privacy, and achieve regulatory compliance through.

Wakefield, Massachusetts, US

• Quality executive for a leading randomization and trial supply management (RTSM) technology service provider supporting pharmaceutical companies, manufacturing companies, and clinical research organizations (CROs) in.
• Advanced an audit and inspection readiness program using proactive and seamless remote hosting techniques that demonstrate knowledge of regulations and expectations while efficiently supporting the audit/inspection.
• Implemented a global cross-training initiative together with expanding the team to develop talent and promote succession planning within a group that had previously experienced high levels of turnover at both.
• Refreshed an internal audit program to be risk based while allowing for more frequent, smaller scope audits. resulting in a 100% increase in audit coverage in the first year.
• Implemented a mentorship program to build future quality leaders as well as fostered a develop-from-within approach that builds upon individual expertise, readying them for advancement into more technical positions.
• Collaborated with product to implement a quality review of elevated risk and regulatory related requirements for a new platform, ensuring quality-by-design principles upstream within the software development life cycle.

Research Triangle Park, NC, US

• Quality assurance executive for a technology-driven service company that performed randomization and trial supply management (RTSM) for pharmaceutical/manufacturing companies and clinical research organizations (CROs).
• Implemented a quality oversight program to monitor the corporate state of quality while partnering with operational stakeholders to drive quality improvements and meet corporate objectives:­ - Initiated quality metrics.
• Established a new global quality management system (QMS) that served the company’s strategic direction and regulatory compliance of high-risk RTSM services, including 21 CFR Part 11. Ensured flexibility and scale of.
• Elevated regulatory inspection support standards. Defined checkpoints and rapid response techniques, resulting in increased customer satisfaction
• Modernized audit hosting, creating efficiencies and allowing an audit-anywhere approach. Refreshed to support deeper remote auditing due to COVID-19, ongoing business objectives, and sponsor oversight obligations
• Served as key client representative and escalation contact. Presented quality governance at client meetings and bid defense

Durham, North Carolina, US

• PERCEPTIVE INFORMATICS Subsidiary of Contract Research Organization, PAREXEL, providing software and services to pharmaceutical companies that bring efficiencies to the clinical trial process.Director, Process Quality.
• Co-Host of FDA inspection, leading team to successful outcome with no observations, plus two inspections as Support Lead.
• Managed 65 sponsor audits worldwide in 2007, hosting approximately 30%.
• Responsible for update of over 50% of the Quality System in 2007, resulting in significant improvements to processes and compliance.
• Increased internal audits by 30% and audit coverage by over 100% in one year.
• Restructured CAPA program, promoting active management and improving tracking efficiencies by over 200%.Director of Validation, Voice and Data Operations (2005 to 2006)

Framingham, MA, US

• STAPLESWorld's largest office products company.
• Led and performed integration and system level testing of the retail Point of Sale system used for all Staples stores. System included the customer-facing sales application as well as interfaces that support credit.
• Developed and implemented global QA Methodology processes as first documented elements of quality system, increasing test coverage by over 100%.

Paris, France, FR

• CAP GEMINI TELECOMMUNICATIONSConsultancy company. Local office was a software provider for major telecommunications companies.
• Established QA standard for regional office based on regulated standards (ISO, DoD, and FAA) yet tailored to suit the rapid development cycle of the commercial telecommunications industry.
• Performed testing of toll free number and virtual private network ordering system. Trained novice team of engineers to apply QA standard and document testing results.

Arlington, VA, US

• RAYTHEON COMPANYTechnology leader specializing in defense, homeland security, and other government markets throughout the world.
• Defined testing approach and led testing teams for several major government projects including a weather sensor integration program, wind shear detection program, and deployable combat weather forecast system.
• Spent 2 months in Hong Kong coordinating the final stages of radar system integration for new airport. Single-handedly organized and executed all site acceptance tests, recovering nearly 2 weeks of installation-related.

Reston, VA, US

• TITAN CORPORATIONProvider of information and communications products, solutions, and services.
• Responsible for all planning, procedure development, and conduct of test programs for wind shear detection radar system and medical laser imager based on internal and government test standards, including DoD-STD-2167A.
• Performed and managed on-site radar testing and supported government representatives at Oklahoma City, Houston, Memphis, and Denver airports.

Ms, Physics

Bs, Physics