Brandon Buchanan Email & Phone Number

Chapel Hill, NC, US

Provided Data workstream leadership and senior project management for complex supply-chain ERP implementation; workstream consisted of ~35 contract and permanent business, data analyst, development, and testing resources and was accountable/responsible for GxP-compliant data extraction, construction/transformation, and loading from multiple sources into.

Executed planning, kickoff, and leadership for lab integration projects (LabX, Scitara, Chromeleon) with LabVantage and other lab systems. Includes contractual development with vendors, project planning, and early requirements-gathering and technical architectural development in the form of multiple workshops.Led successful project execution with.

Designed and implemented data migration strategies as technical architect and senior PM across multiple franchises for data migration associated with PLM (Windchill) solution, using a combination of Agile and waterfall methodologies. Built and implemented data migration tooling to identify data needing cleansing and/or transformation.

Enterprise-wide system architectural and integration work / project planning, and multiple-system data migration planning and execution. Identification and mitigation of risk.

Rahway, New Jersey, US

Project-managed global project component as data readiness lead. Designed standard work and processes for data cleansing for a complex, multi-phase SAP-based IT implementation. Led global meetings with project personnel across 24 Merck production sites to cleanse and construct critical data; tracked progress; oversaw development of error reports and.

Bagsværd, DK

Assumed responsibility for site-wide IT security software installation and physical asset security projects; undertook a redesign of the project (which was initially set at project spend of $2.2 mn). I analyzed the project and determined that 96% of the value of the project could be delivered for 37% of the cost while saving 1+ years of execution time and.

Principal and CEO for Throne Research, a pharmaceutical consulting firm dedicated to helping our clients rapidly advance and optimize their competitive edge and prevent or reverse compliance problems through sustainable quality systems design and implementation, production operations and supply chain optimization, gap analysis and remediation program.

Rahway, New Jersey, US

I led the Wilson Technical Services group, which was responsible for packaging engineering, site change management, product launch, and SAP stewardship for the Wilson, NC Merck Packaging Center of Excellence (the facility packages oral solid dose, vaccines, sacheted powders, and medical devices for US and international markets). Group responsibilities.

Rahway, New Jersey, US

Responsible for management of packaging operations in Bottles Integrated Process Team (IPT). My responsibilities included the following:* I motivated 35+ operator resources to safely and compliantly execute weekly packaging schedules on or before time and within overtime constraints for solid oral dose products, glass-vial products, and medical devices..

Rahway, New Jersey, US

Responsible for the supplies inspection, printed component quality, and retention groups at a large, high-volume pharmaceutical packaging site. My group and I executed the following functions:* Supplies inspection and release of all solid oral dose and injectable cold-chain bulk product and primary packaging components used in the facility.* Printed.

Rahway, New Jersey, US

Responsible for the Quality Services function at flagship consumer healthcare manufacturing and packaging site. My group and I executed the following functions: * product release* site quality audits* FDA and ANVISA inspection readiness and management (zero observations across multiple inspections)* consumer complaints (investigations, trending, adverse.

Rahway, New Jersey, US

I led a division-wide 21 CFR Part 11 remediation project ($14.5 mn) covering 134 systems and managed the program office – the project was completed three months ahead of schedule and $1.2 mn under budget. I also designed and implemented a divisional risk-based computer system development and validation lifecycle; three systems-focused corporate audits were.

Rahway, New Jersey, US

I developed the divisional 21 CFR Part 11 remediation approach on behalf of Schering-Plough Research Institute (Kenilworth, NJ). I collaborated in the development and review of divisional computer systems validation and quality methodology, and served as the primary quality approver on all hardware and software qualification & validation protocols and.

Brentford, Middlesex, GB

I served as the senior validation consultant for the North American implementation of SAP and related corporate-level applications as part of Glaxo Wellcome's Global ERP Programme initiative. Reporting directly to the validation group leader, I managed other validation resources where necessary and served as responsible lead in our group leader's absence..

Leverkusen, North Rhine-Westphalia, DE

I managed the design and development, IQ/OQ/PQ testing, and implementation of several GAMP Category 4 and 5 database systems, including systems used for environmental monitoring, risk assessment, product surveillance, potency calculation, and test record management. I managed vendor resources for software coding, technical documentation, and validation. I.

I created and led a twelve-member department charged with the design, creation, project management, testing, and delivery of healthcare-oriented web aides for tailored patient/provider education materials. Duties for our group included project management of written content production, and creation and execution of complex test methodologies and test plans.

US

I researched, wrote, and edited technical manuals, online help, and reference materials for a4's premier hospital-based care management, chart management, pharmacy, patient orders, workflow, and laboratory reporting software packages. I became familiar with JCAHO accrediting standards and regulations, HL7 standards, and ICD-9 medical coding requirements. I.

I trained both basic and accelerated medical center computer users in over two dozen word-processing, graphics, and spreadsheet applications in Windows and DOS. I also trained advanced users in Visual Basic programming elements. I created, coordinated, and led workshops, study sessions, and classes in WordPerfect, Word, Excel, and Windows. I wrote, edited.

I researched, wrote, and edited portions of a textbook series being produced by N.C. State University for North Carolina public schools (ISBNs 1-881507-01-7 and 1-885647-01-8). My assignment included coordination of and extensive international travel throughout Central and South America. I also planned schedules and provided day-to-day contact for two.

Bachelor'S Degree, Ba, Political Science, Ba, English

Certificate, Six Sigma Black Belt

Master'S Certificate, Project Management

Education record

Education record