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A dynamic senior leader with extensive, diversified and progressively responsible experience across multiple Information Management, Technology and business disciplines. Demonstrated success in creating and leading high performing global teams in Pharma/Biotech R&D. Expertise in R&D technologies and delivery, IT Compliance with a focus on risk-based delivery and flawless execution, common-sense processes and customer satisfaction. Experience in SDLC development, program and portfolio management, Infrastructure, Operations, effective change management, communications, team building, document management, and interpersonal relations with a highlight on problem solving, negotiation skills and delivery excellence.Specialties: R&D techologies and delivery, IT Compliance, ITIL certified, Six Sigma certified, Portfolio and Project Management expertise, Infrastructure and end user delivery
Pb Consulting - Grc
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Global It Compliance - Grc, Csv, Risk Management, Dr And BcpPb Consulting - GrcCollegeville, Pa, Us
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Global It Compliance - Grc, Csv, Risk Management, Dr/BcpPb Consulting - Grc Jun 2021 - Present
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Global Quality - Computer Systems ComplianceEmergent Biosolutions Jan 2019 - Jun 2021Gaithersburg, Maryland, UsI am responsible for ensuring compliance with applicable GxP guidance and regulations for Emergent’s enterprise and multi-site systems including GAMP5, 21 CFR Part 11 (US) and EU Annex 11. Also responsible for the development and deployment of quality standards and procedures, oversight of computer system validation activities (including protocol, test script, and report approvals) and leadership of continuous improvement efforts guiding software validation, data governance/data integrity, risk assessments and lifecycle maintenance. Lifecycle maintenance activities include change management, deviation handling and CAPA planning and execution. -
Pb Consulting GrcCatholic Health Services Of Long Island Jul 2018 - Jun 2019Responsible for implementing a Risk Management Program for the Catholic Health Services of Long Island (CHSLI) Organization to meet HiTrust requirements. Delivered a Risk Management Program, a sustainable Risk Register, and all related processes and procedures to assure that roles, responsibilities and deliverables are clearly defined. I also assumed the responsibility to deliver the IT Disaster Recovery Strategy, in adherence to HiTrust requirements. Both the Risk Management Program and the Disaster Recovery Strategy were reviewed and assessed by HiTrust assessors, passed all required criteria, and were delivered on time and under budget.
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Igm Head Digital Medicines - Global Business PartnerNovartis Jan 2016 - Jun 2018Basel, Baselstadt, ChLead the Novartis IGM function for Digital Innovative Technologies and Global Business Partnering to build the foundation that information and IT systems are adequately protected against unauthorized disclosure (confidentiality), unauthorized alteration (integrity), unavailability (availability) and non-compliance. -
Global Head It Quality & ComplianceAstrazeneca Jan 2014 - Dec 2015Cambridge, Cambridgeshire, GbResponsible for Global IT Quality & Compliance, IT Business Continuity & Disaster Recovery and IT Risk Management. Delivered a global strategy for delivering common and consistent Regulatory Compliance practices, including CSV, Sarbanes Oxley, Privacy and Import/Export. Developed global Business Continuity and Disaster Recovery Strategies, driving optimal efficiency for AZ Critical Set of Applications. Built a high performing global team to address effective capabilities and delivery, geographic sustainability, and localized flexibility as needed. -
Sr. Director, It Information AssuranceMedimmune Apr 2011 - Jan 2014Gaithersburg, Maryland, UsResponsible for IT Information Assurance at Medimmune, including IT Quality and Compliance, GxP compliance, Risk Management and Security, IT Assurance/Audit, Policies and Standards, Business Continuity and Disaster Recovery. -
Director It Infrastructure And End-User ComputingEndo Pharmaceuticals May 2007 - Apr 2011Malvern, Pa, UsA dynamic senior leader with over 23 years of diversified and progressively responsible experience across multiple Information Management and Technology disciplines. Demonstrated success in creating and leading high performing teams (globally), with a focus on flawless execution and customer satisfaction. Expertise in IT Infrastructure/End User compting, Program and Project Management, communications, team building, Documentun and Document Management systems, compliance and interpersonal relations, with a highlight on problem solving, negotiation skills and delivery excellence. -
Director - Im ComplianceCentocor R&D 2001 - 2007UsCreated an organization to deliver regulatory and statutory compliance solutions for the global Centocor R&D organization. Aligned CSV program with J&J affiliates to create scalable solutions leveraged across multiple J&J units. Developed Centocor R&D IT Business Continuity Plan, integrated with CNTO R&D Global BCP. Created a global Records Management program, reaching a “top 25% ranking” across J&J within the program’s 3rd year of existence. Provided leadership for Applications Support, Documentum/Doc Management, and the Technology Infrastructure team, growing the support center from a single unit (Centocor R&D) to an organizational structure to provide infrastructure support across 5 J&J companies. -
Manager - Product & Portfolio SolutionsJohnson & Johnson/Ncs Dec 2000 - Dec 2001New Brunswick, Nj, UsResponsible for development and implementation of a portfolio management team to plan and execute all infrastructure projects for affiliate organization(s), including company specific projects and enterprise-wide projects. Created a high performing team of Project Managers, with a focus on Project Planning and effective, efficient and flawless delivery. -
ManagerMcneil Consumer Healthcare Oct 1988 - Dec 2001UsManaged IM resources for several Business functions, including QA, Manufacturing, Professional Sales, HR and Finance
Pete Buckwalter Skills
Pete Buckwalter Education Details
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Saint Joseph'S UniversityGeneral -
Harvard Business SchoolPrinciples Of Leadership -
Montgomery County Community CollegeBusiness -
Saint Joseph'S UniversityGeneral -
Saint Joseph'S UniversityGeneral
Frequently Asked Questions about Pete Buckwalter
What company does Pete Buckwalter work for?
Pete Buckwalter works for Pb Consulting - Grc
What is Pete Buckwalter's role at the current company?
Pete Buckwalter's current role is Global IT Compliance - GRC, CSV, Risk Management, DR and BCP.
What is Pete Buckwalter's email address?
Pete Buckwalter's email address is pe****@****ons.com
What is Pete Buckwalter's direct phone number?
Pete Buckwalter's direct phone number is +148421*****
What schools did Pete Buckwalter attend?
Pete Buckwalter attended Saint Joseph's University, Harvard Business School, Montgomery County Community College, Saint Joseph's University, Saint Joseph's University.
What skills is Pete Buckwalter known for?
Pete Buckwalter has skills like Program Management, Quality Assurance, Itil, Computer System Validation, Pharmaceutical Industry, Cross Functional Team Leadership, Six Sigma, Project Management, 21 Cfr Part 11, Change Management, Sdlc, Gxp.
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