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 customized S4/HANA solution. Within this, I also:Oversaw totality of Release 2 data construction and transformation, resolving issues and removing obstacles to ensure adherence to timelines and next-phase phase entrance criteria. Advanced a holistic data verification strategy; developed and recommended strategies for data risk framework, business verification, preload and postload testing approach, and data-handling platform validation, and coached business, technical, and validation/quality resources on same. Recommended specific changes to content of functional design specification (FDS) documents to include extraction, construction, and transformation rulesets and identified the framework for ruleset capture. Developed and resourced approach to elucidate content and provision of rulesets in FDSs in support of test script development.Recommended changes in approach for data-driven defect resolution process to improve defect exit rate and assist with GxP compliance; coached workstream resources on same. Collaborated on delta/cutover requirements, dependencies and scheduling; provided direction on scheduling requirements. Facilitated staffing analysis, headcount justification, and hire/fire decisions within workstream. Planned and ran multiple workshops for workstream, covering above and other topics.

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 purpose-built trackers using hybrid agile/waterfall system lifecycle methodology; timelines brought in 2-3 months ahead of schedule.

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 ensured adherence to schedule. Data cleansing was completed on schedule and addressed for 5000+ material master records. Current global project underway now for supplier records. Based on my prior SDLC expertise, developed the approach for preload and postload data testing in support of Release 1. Coordinated the activities of the IT team, the testing team, and Quality Assurance. Wrote test scripts and created testing files; participated in and oversaw testing, which completed with no errors one day prior to due date. This was not part of the group’s responsibilities and was additive effort on my part and additional to my own role. Developed functional approaches for supplier data in concert with functional lead directors. Developed master data mapping document for Release 1 material master source and target data streams.Developed and implemented data standards/governance approach and methodology (conceptually new to Merck); authored numerous standards in support of parent project rollout. Assisted with coordination and oversight for data cleansing for analytical specifications (unstructured data stream). ~3400 document specifications were recoded into SAP records, verified and uploaded. My efforts also included creation of a unique subteam to promote expedient records review. Diagnosed issues and identified approaches for establishing incidence rates for hypercare on behalf of project leadership team.

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 $1.4 mn.Assumed responsibility for sitewide MES (manufacturing execution system) project and delivered project through funding milestone; optimized project to deliver same deliverables while saving 43% of original project cost while transitioning to and simultaneously training other project managers in PM best practices. Developed and presented multiple final funding-gate project analysis presentation for delivery to site leadership team. Mentored other project managers and assisted them in project optimization. Redesigned and implemented department tools for resource planning, budgeting, project planning in MS Project, and scoping. Note: work performed from May 2018 to August 2018 was executed for Novo Nordisk under contract to LMN Services, Inc; duties were the same as noted above.

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 execution, and efficient, focused project management. Throne's specialties include the following:Quality systems/process design and implementation (change control, deviation management, batch release, document and labeling control, auditing, annual product review, good documentation practices, data integrity)Compliance gap analysis and remediationProduction operations optimization and training; controlled substances handling and accountabilityEquipment/instrument qualification and metrology program developmentProcess, packaging, and cleaning validation program developmentComputer validationSoftware systems design, integration and implementation (compliant to FDA 21 CFR 11 and data integrity draft guidance; IT system anti-malware hardening)Project/program management (site/divisional capital level - engineering, software, product launch)Lean program implementationNovel analytics developmentWe bring an interdisciplinary approach to everything we do and have senior experience in all elements of pharma quality operations, production operations management, supply chain optimization, and remediation program planning and execution. In addition to our consulting expertise, we bring unique capabilities in systems design and implementation -- our suite of pharma-compliant software products are designed to mesh with your IT infrastructure and quickly provide superior electronic solutions and analytics that grow with you. We've worked with pharmaceutical, biologic, medical device, and consumer healthcare firms who market oral solid dose, liquid, encapsulated, and injectable forms as well as medical devices.

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 included the following:* Assessment and coordination of all product-impactful changes at site, including product launch, product configuration, engineering, IT, and supplier-side changes. Group was responsible for project/program management of US and international launches for site.* Site-level SAP stewardship, training, and technical support, including management of SAP master product, line and recipe data for the site. Group also managed SAP MES functionality, including design, development, and fielding of electronic batch records and line-level support and issue resolution for operations personnel. * Trackwise system stewardship (primary system used for all levels of change control), including training and technical support. * Product serialization; our oversight also included management of the packaging anticounterfeiting devices program. * Technical approval of primary product contact componentry and printed components (labeling, cartoning, PI/PPI) used at site in production of US and multiple international markets within launch lead times.I also personally:* Developed project/program management best practices and chaired the site change control and project management Tier meetings. * Executed other site-critical projects at the direction of the site leadership team, including identification of lean projects, validation of project direction and ROI with complex data analysis, and project execution.* Executed two deployments to Operations to train Operations managers and bring about improved performance in specific production areas. * Collaborated as SME on PLM solution development.

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. Schedule adherence for 2014 was 96.6%. * I oversaw critical product launches on behalf of my department. * I directly took charge of an at-risk product launch and oversaw engineering qualifications, key safety steps, line training, and documentation activities to support the launch, which was executed on time and in full with no errors. * I initiated and then took the lead on an operations-wide compliance and error-reduction initiative, driving a 52% reduction in documentation errors across the Bottles, Blisters, and Vaccines departments. * I ensured group adherence to GMPs, site SOPs, and safety requirements. I responded to all quality audits, planning and executing CAPA as needed. * I executed continuous improvement projects through Kata and Kaizen activities to improve production line capacity and maximize operator efficiency.* I supported first-of-kind-for-site implementation of serialization project within Bottles area. * I planned, executed, and monitored training for operations personnel, ensuring that personnel completed all required training before due dates.* I served as a stakeholder for SAP development related to Operations, especially in the area of MES/electronic batch records completion and error resolution. * I served as the primary Operations point of contact for on-the-floor interactions with FDA and international regulatory authority inspectors. * I redesigned the site hygenic zoning program to reduce the need for shoe covers, significantly enhancing operations-floor safety.* I was responsible for hiring, development, and separation of permanent and agency employees.

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 components inspection and release, including master artwork file approval, printed components (circulars, patient inserts, labels, cartons, other materials).* Execution of retention program requirements for production batch records and retention product samples.I took over the group immediately prior to a tripling of the group’s workload. I directed lean changes (5S, mini-Kaizen, metrics establishment) to ensure the group’s size remained flat while enabling critical-path support for on-time release and improved compliance. I worked with Procurement and Engineering to optimize specification tolerances to site packaging equipment.I provided primary input to vendor quality agreements and guidance to vendors on Merck quality system requirements.I audited vendor facilities and provided feedback on vendor production and quality systems. I negotiated and tracked vendor CAPA to completion and ensured defective vendor materials were returned for credit.I completed implementation of a tailgate sampling program and other lean activities, ensuring the ability to absorb 20% additional workload while supporting compliance and keeping group size flat. Redesign of program included risk assessment, improvement of vendor methodologies for ANSI sampling and sample storage requirements.I provided oversight and intervention where necessary for the transfer of a major retention program as part of site consolidation activities; over 5,000 samples were transferred successfully in a two-month timeframe.I redesigned and then managed the compendial testing program for product contact materials.

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 event senior review)* change management (local, non-local, and temporary changes)* annual product review* documentation issuance/revision/management (SOPs, master packaging records, testing standards, equipment setup sheets)* oversight of laboratory instrument qualification and calibration programs* oversight of IT system lifecycle program across multiple sites I also served as the primary quality approver for all site equipment, instrument and IT systems qualification/validation protocols and reports, and the primary quality approver for all product process, packaging, and cleaning validation protocols and reports. I was responsible for sponsoring and completing investigations and investigation trend reviews at the group level.I was an acting sponsor for our site's LIMS replacement initiative. I managed capital planning, forecasting, and reporting for our Quality group, with over $1.9 mn savings realized during assignment.

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 returned with zero audit observations.With a team, I collaborated in the development and fielding of several database systems to manage site SOPs, batch record review, and equipment setup sheets.

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 summary reports. I conducted systems audits, tracked open issues to closure, and served as the primary group contact for our corporate audit group.

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. I served as a consultative resource for our integrated quality management system project methodology and implementation. I provided regulatory guidance on project policies to corporate-level validation and IT project management personnel and served as a technical design resource with respect to 21 CFR Part 11 issues. I authored the departmental operating plan and directed the development of site audit plans. I also co-authored the North American Regional Project Quality Plan and participated in its review across multiple sites.

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 served as our department's primary compliance resource, and as the first contact for internal and external regulatory communications. I planned, conducted, and compiled results for audits of the department's systems and documentation, and recommended remediation strategies where necessary. I managed the department's project documentation library for 116 deployed and archived software applications, including requirements, specifications, IQ/OQ/PQ validation protocols, standard operating procedures, and change control requests and approvals.

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 for the browser-based and demand-printing applications used to deliver content. Clients included Glaxo Wellcome, Roche Pharmaceuticals, and the American Heart Association. I coordinated with managers from graphics, web, science, and database departments to implement project design, development, testing, and deployment plans across print and web.

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 collaborated with our Quality Assurance Testing group in software testing and error-tracking/resolution per industry standards for high-reliability software. I negotiated editorial schedules for multiple short and long-term projects, coordinating with project managers, planners, quality assurance personnel, and other writers/editors, and served as a project leader for department-wide documentation efforts. I led department meetings to set style and usage standards for technical manuals, online help, and online documentation. I built, tested, and implemented a sophisticated set of hard-copy, online help, and online documentation templates.

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, and produced basic and advanced manuals for WordPerfect and Windows.

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 writers producing copy for the textbook series. When not serving as an editor, I supported basic elements of our office's information technology infrastructure and served as first-line technical contact.

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

Certificate, Six Sigma Black Belt

Master'S Certificate, Project Management

Education record

Education record