JOHN EDENHOFNER

215-534-3556 – johnedenhofner.pmp@gmail.com
www.linkedin.com/in/johnedenhofner

Senior Project Manager

Highly accomplished Senior Project Manager with Project Management Professional

(PMP) and CSM certifications. Extensive experience in the pharmaceutical industry
including top Fortune firms such as Genentech, Regeneron, and Sanofi. Expert in
project planning, software development life cycle (SDLC), cGMP system
documentation, SaaS implementation projects, requirement specifications, software
procurement, software validation testing, and risk management.
 Led Veeva Quality Suite (QMS) projects which included integration with Veeva
Clinical. Projects were challenging as they were tightly scheduled between Veeva
R releases and other Veeva projects. Tested configurations had to be deployed
into Production with the same R release version as the test environment.
 Managed a Veeva QualityDocs v.16 Configuration Upgrade project which included the
migration of all outstanding GxP documents into the QualityDocs Vault.
 Delivered a Veeva QualityDocs workflow implementation for Clinical Review of all
external clinical presentations and communications including visual media as well
as formal scientific papers. The multi-disciplinary project team featured legal,
regulatory affairs, medical affairs, and quality experts.

CORE COMPETENCIES

21 CFR PART 11 Project Management Metrics Project Change

Reporting Control
ETQ Veeva Quality Suite Use Case Testing
(QualityDocs & QMS)
Validation Plan Scope Management Risk Management

PROFESSIONAL EXPERIENCE AND ACCOMPLISHMENTS

EDENHOFNER
CONSULTING LLC 2011-PRESENT

Senior Project Management Consultant

Senior project management consultant for Life Sciences clients. Providing cGxP project
expertise for system implementation and GxP validation for both established and first time NDA
submitting companies. Managing high profile projects on critical timelines with defined budget
limits.
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CLIENT ENGAGEMENTS

ASTRAZENECA 2023-2024
SAP Project Manager

Project Manager for a Global Payments Transparency (GPT) project analysis resulting in a completed
business case for a new GPT system with a proposed $5.1 million project budget.

 Prepared a Request for Proposal (RFP) package sent to the top 5 GPT Reporting system
vendors. Collaborated with the RFP team members to evaluate vendor responses as part of
completing a business case for a new GPT system.

 Collaborated with IT Data Architect, System Owner and IT Support Manager to cost estimate an
in-house build for a new GPT system. Team considered twenty data source system integrations
with a data lake built in the Snowflake database management environment. Data source systems
included SAP ECC, S/4HANA, Concur, and Veeva CRM Events.

 Created presentation materials to present the GPT system business case to senior financial
executives.

REGENERON 2020 - 2023

Senior Project Manager

Project Manager for multiple Veeva QMS workflow implementation projects and a Veeva QualityDocs
workflow project. Responsible from managing projects’ timelines and budgets. (Total budget $1.25
million)

 Managed a Veeva Quality Suite project to implement both a Serious Breach workflow and an
Audit workflow system. Project scope included integration with Veeva Clinical for the support of
clinical study audits. The project was delivered on time and on budget.

 Managed a Veeva Quality Suite Pharmacovigilance Compliance workflow system project for the
management of Quality Safety Events. The project followed an agile methodology.

 Managed a Veeva QualityDocs Clinical Review Committee workflow project involving a multi-
disciplinary team of Clinical, Legal, Medical Affairs, and Quality stakeholders.

 Prepared initial project planning for a DocCompliance migration to Veeva QualityDocs project.
Responsible for budget estimates to cover QualityDoc workflow configuration, document and
meta data migration, and Veeva Quality Vault integration with ComplianceWire (LMS).

 Collaborated with Legal, Quality, and Procurement on three Veeva vendor Statement of Work
agreements.
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SPARK THERAPEUTICS 2019 - 2020

QMS Program Project Manager

Project manager for a QMS Program with a ComplianceWire GxP LMS implementation project,
a QMS implementation project and a Document Management System implementation project.
Responsible for managing projects’ timelines and budgets. (Total program budget $2.3 million)

 Led a validated ComplianceWire GxP LMS project with a data migration workstream
(Training items and historical employee training records.) Project was delivered on time
and on budget.

 Managed a Quality Management System implementation project with multiple planned

phases (CAPA and Deviations, Change Control, Product Complaints, Supplier
Qualification and Audits). The project included change management to address moving
from a manual system to an electronic system.

 Collaborated with Computer System Validation, Enterprise Applications and IT

Compliance on a Veeva vendor Statement of Work.

ALKERMES 2019
QMS Senior Business Analyst/Project Manager

Business Analyst for Global QMS Deviation and CAPA workflow project to purchase and
implement across all divisions a system reflecting harmonized processes.

 Created Business Requirements Specifications and Use Cases for the Vendor RFP.

WORTHINGTON INDUSTRIES 2018 – 2019

QMS Senior Business Analyst

Business Analyst for the Quality Management System implementation across all major divisions:
Steel, Engineered Cab solutions, and Pressurized Cylinders. Worked with project teams to
ensure compliance with regulatory requirements such as FDA, CAPA, CLIA, GxP, HL7 as well
as internal policies and processes.

 Created Business requirements specifications for the Quality Management System.

 Collaborated with key business stakeholders to identify and implement business process
improvements across all divisions

 Organized and conducted cross divisional, including joint ventures, discovery design
sessions to capture and resolve common business and regulatory requirements.
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SANOFI 2017 – 2018
Project Manager

Project manager for an SAP GxP project to interface SAP Product and Batch data with a Quality
Management System (Batch investigations). Implemented SAP Batch Alert functionality to flag
batches, in SAP Batch Release, which are part of open Quality Management System
investigations.

 Led a virtual project team based at four locations in two countries to implement an SAP
Batch Release interface project in parallel with a Quality Management System site
deployment project.

 Coordinated application testing for the Windows 10 platform for the two major North
American vaccine production sites. Collated the testing results and provided
management with the number of users affected by the platform upgrade and associated
remediation strategies and timelines.

 Managing a Beckman LIMS Decommissioning project involving identifying electronic

records and their associated record types to preserve in an electronic records archive
according to appropriate records retention schedules.

SCIENCE 37, INC. 2017

Project Management Coach

Promoted best practices for a successful Compliance Quest Quality Management System SaaS
implementation using minimal configuration within ninety days. Reviewed project plans with the
project lead to ensure meeting the business’s strategic goal of implementing both the document
management module and training management module on time, on budget and 100% of users
trained within a month of Go Live.

 Identifying, with the project lead, stakeholder needs for the migration of controlled
documents into the Compliance Quest document management module.

 Examined validation plan to verify that 21 CFR Part 11 functionality is correctly tested.
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INTARCIA THERAPEUTICS, INC. 2016 – 2017

Senior IT Project Management Consultant

Project Manager for cloud based MasterControl Quality Management System (QMS) Software
as a Service (SaaS) implementation. Managed a NuGenesis LMS Electronic Laboratory
Notebook (ELN) project and GxP. Delivered a NuGenesis LMS SDMS project on an aggressive
three month timeline. Implemented Veeva QualityDocs configuration upgrade. Presented
Project Progress Reports weekly to the CIO and his direct reports.

 Led a Veeva QualityDocs v.16 Configuration Upgrade project, on time and on budget, to
establish the document types and document workflows needed to bring all GxP
documents into the controlled electronic document control environment. Project
included migration of all GxP documents previously outside of Veeva QualityDocs into
the Veeva Vault.

 Headed a Quality Management System implementation (Master Control) project from

RFP to Off the Shelf implementation stages. Implemented CAPA, Deviation, Training
(LMS), and Change Control modules. Worked with Quality managers and the Training
Director to ensure GxP requirements were met within a six month window.

 Validated a NuGenesis LMS ELN configuration project for a Quality Control laboratory’s
pharmaceutical services group. Project includes the qualification of five analytical
reports used within the ELN module.

 Managed NuGenesis LMS SDMS project for a Quality Control laboratory, on time and on
budget, for the archival and retrieval of scientific instrument data from seven different
instrument types.

CUBIST PHARMACEUTICALS, INC. 2014 – 2015

Business Analyst/ Configuration Specialist

Performed Part 11 requirements gap analysis. Authored a Functional Risk Assessment, use
case scenarios, and project meeting minutes.

 Collaborated with stakeholders to author a Functional Risk Assessment for a TrackWise

Complaints Handling workflow and a Field Alert Reporting workflow.

 Performed a Part 11 requirements assessment of previous TrackWise deployments’

requirements specifications to determine the scope of Part 11 general requirements
testing.

 Created Complaint Handling use case scenarios.

 Created a Complaint Handling report using Crystal Reports 2008.

 Wrote all project meeting minutes that were issued by the project manager.
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CELGENE 2011 – 2014

Business Analyst/ Configuration Specialist

Managed the business relationship with the global CAPA and Deviation manager to ensure
CAPA and Deviation modules met new Quality process change goals. Responsible for CAPA
module and Deviation module upgrades, requirements gathering, and CAPA module and
Deviation module system integration testing.

 Collaborated with stakeholders to document new requirements for ETQ CAPA and ETQ
Deviation modules. Responsible for creating Requirements Specifications, Data
Dictionaries, Use Case Testing, User Account administration. Reviewed Business Objects
Report Specifications for completeness of reporting requirements. Collaborated with
training team lead for the preparation of CAPA and Deviation training materials and course
outline.

 Configured workflows, created groups for document assignment, created views for CAPA
and Deviation modules (main form and action forms), added new form fields and modified
existing fields. Wrote python code to perform field validation on form and to enforce
required data entry based on event conditions.

TECHNICAL SKILLS

Platform: Unix, MS Windows Server

Software: MS Project, Sharepoint, Planview, ChangePoint, Smartsheet, ServiceNow,
Concerto, Documentum eRoom, PL/SQL, Rational ClearCase, Rational ClearQuest,
Crystal Reports 2008/11/8, TrackWise 8.4.1/7.0/6.0, EtQ Reliance 10.0/8.0/6.2,
Veeva Quality Suite (Quality Docs & QualityDocs), MasterControl, SQL Navigator,
SQL Server Reporting Services (SSRS), Toad, Visio, MS Excel, MS PowerPoint,
Test Director, WinRunner
Database: Oracle 11g/10g, MS SQL Server, MS Access
Programming Languages: Python, Visual Basic, MS Office VB, VB for MS Excel, C,
Oracle SQL/Plus, HTML, XML, Java, JSP

EDUCATION

Bachelor of Arts in Mathematics/ (Minor in Physics) - Temple University, Philadelphia, PA

PROFESSIONAL CERTIFICATION

Project Management Professional (PMP) – Project Management Institute

Project Management Certificate Program - Bucks County Community College
Certified ScrumMaster – Scrum Alliance

PROFESSIONAL ASSOCIATION MEMBERSHIP

Project Management Institute

Scrum Alliance
CompTIA
Philadelphia InfraGard