Senior Project Management Consultant

* Program Quality Management as part of the Methodology & Tools Team
* Defining ERP Methodology for S/4HANA Platform
* Creating or reviewing SOPs, Strategies, Work Instructions and guidelines
* Create or modify templates to fit CSV, good Project Management practice and platform
requirements
* Support and train project managers / project team members on the platform Methodology
* Review existing methodology for improvement
* Align changes with compliance and information security experts
* Review project documentation to ensure methodology compliance

* Global Program Quality Manager, Alcon, Switzerland, Global SAP Implementation Program
(Scope of Globally 67 Sites - EMEA, APAC & US)
* Program Quality Management as part of the Program Methodology & Tools Team
* Based on the Methodology framework, Validation approach, Information Security Risk
Management and Novartis Financial Control Manual framework.
* Conducting project phase reviews for Release Build-, Pilot -and Rollout Projects (on-site and
offsite)
* Create final project review report
* Impact Assessment on any identified observations and recommendation to Program Management /
Project Steering Committee
* Conduct Reviews for following work streams: Project & Quality Management (PQM), Business
Process (BPO) System Development (SYD), System Delivery (SYD) , Data Migration (DMI) ,
Organizational Change Management (CCM) , Technical & Infrastructure Management (TIM) &
Service Delivery (SED)
* Review of CSV and project management deliverables and actions
* Verification of evidence provided by the Project Team to the Project Review Checklist.
* Reviewing project roadmaps against project WBS and project review check lists.
* Write guidelines to review project deliverables
* Provide support in enhancing the Program Methodology for three Project Scenarios: Release
Build, Standard and Rollout Waves
* Provide support and guidance for Lead Project Quality Managers and Project Managers on Project
Methodology and the Review Checklist.

* Compliance according to CFR 21 Part 11 & Good Documentation Practice, Novartis CSV SOP,
Novartis QM Manual for Computerized System Validation
* Global SAP Changes
* BMC Remedy Changes
* Support Global Projects in CSV relevant topics
* CAPA review in Trackwise
* Test Report Reviews in HP ALM Test Management
* General Review of GxP relevant SOPs, Validation Plans / Reports, Traceability Documents,
Lifecycle Documents, Test Documentation
* Supporting Risk Management Assessments

English
* Support of national and international Projects
* Project size from small to large
* Compliance according to GAMP, CFR 21 (820, 11) & Good Documentation Practice.
* Compliance according to IGM (Information Governance Manual) and relevant ERP CC Work Instructions
* Training of project teams
* Review of Documents
* Project Reviews (Project Phase Reviews)
* Test Management (QA related)
* Change Management (QA related)
Project Samples for the Novartis Quality Manager Role:

* Cross-divisional blueprint project for a Supply Chain / Production Planning solution (part of
a 35mio. USD Program), Project Size: large, project impact: international, location: on-site
(Slovenia, Ljubljana)
* Areas covered:
* Supply Chain & Production planning
* Demand planning solution
* Master Data Management

* Track and Trace Rollout for Sandoz Sites
* Delivery and validation d the Sandoz Track and Trace Core packaging interface solution
* Integration of SAP AII/OER Core Packaging interfaces.

* Freight Cost Management solution development, Project size >1000MD (Large) , Project impact:
National (Pilot Site):
* Increase of savings (estimated at 5%) by automated freight cost management processes
* control of cargo services of defined standards (approval process
* Verification of freight invoices against system cost calculations
* Automatic booking of provisions or rated receipt postings
* Analysis of KPIs Reporting
* Select the correct freight service providers in accordance with GxP requirements

* Distribution outsourcing to an external 3rd party warehouse provider, Project size >500 MD
(Large), Project Impact: National
* Technical setup to reflect the new material handling processes with new 3rd party
warehouse provider.
* Integration of a standardized interface for the new 3rd party warehouse provider


* Barcode Scanning solution for spare parts inventory management, Project size: >100 MD (Midsize),
Project Impact: International
* increase savings by inventory optimization and price reduction
* standardization of the processes in different sites

* Implementation of a functionality which allows Sandoz business users to show the relationship
between 3rd party suppliers/ manufacturers and Sandoz sites (Manufacturing and Commercial) as
well as respective products, Project Size: >100 MD (Midsize), Project Impact: International
* Establishing a link of supply chain/purchasing and QA related data available and local
sites maintain
* Implementation of a Notification Solution in case of Quality Alerts

* See Project Examples

International project (large)
* Validation of Oracle E-Business Suite 12.1
* Consulting Offer:
* General validation approach for the Oracle system in terms of GxP Compliance
* Legal requirements (FDA, EU)
* System documentation -Lifecycle-* requirements management and traceability
* Risk-based approach
* Test Management
* Document Management
* Project Standards
* Validation Team Lead
* Training of management, project team members and end users

Project Management Officer in a software solution development project, assistant to the Project
Manager and Enterprise Architect, responsible for compliance with project guidelines, resource
and budget planning

* assist in resource- and finance planning
* organizing meetings, managing protocols-, the project database and all project relevant documents
for Germany and Switzerland
* Controlling: review actuality and quality of IT documents, project database, time reporting, SDLC
and ZPMF processes