freiberufler Project/Integration Manager - CISA / CSV / GMP / Agile / Prince 2 auf freelance.de

Project/Integration Manager - CISA / CSV / GMP / Agile / Prince 2

online
  • auf Anfrage
  • Basel
  • Weltweit
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  • 21.06.2021

Kurzvorstellung

A well-rounded senior leader in the Pharmaceutical/Biotech & Finance Industry with diverse experience and expertise in Governance, Compliance, Business Relations, Solution Discovery & Delivery, M&A, Outsourcing, Program & Project Management.

Ich biete

  • 21 CFR part 11
  • CISA (Certified Information Systems Auditor)
  • CSV
  • Diplom Informationswirt
  • GMP
  • ISO9001
  • ISO/IEC 20000-1
  • ITIL
  • PRINCE2
  • V-Model

Projekt‐ & Berufserfahrung

Lead Auditor
Kundenname anonymisiert, Basel
5/2021 – 6/2021 (2 Monate)
Life Sciences
Tätigkeitszeitraum

5/2021 – 6/2021

Tätigkeitsbeschreibung

GAP Assessment of the local datacenter, IT Security measures & GDPR

My tasks:

 Define strategy for the assessment
 Set up Kickoff meeting and questionnaires
 Interview different stakeholders
 Collect all needed information
 Prepare the GAP Assessment with recommendations
 Set up operations for GDPR and follow action plan for closing the gaps

Eingesetzte Qualifikationen

CISA (Certified Information Systems Auditor)

Project Manager for a "SAS Validation" Project
Kundenname anonymisiert, Basel
10/2020 – 2/2021 (5 Monate)
Life Sciences
Tätigkeitszeitraum

10/2020 – 2/2021

Tätigkeitsbeschreibung

 Prepare Project Charter
 Define CSV & technical approach
 Setup Project team and Project Plan and set clear responsibilities
 Manage the Project and reporting to the Steering Committee
 Review and approval of entire CSV & lifecycle documentation
 Coordinate Project team and stakeholders
 Facilitate meetings
 Ensure that all required project documentation is delivered and all tollgates are passed

Eingesetzte Qualifikationen

PRINCE2

Project Manager - E-signature (DocuSign) application Implementation
Kundenname anonymisiert, Basel
3/2020 – 7/2020 (5 Monate)
IT & Entwicklung
Tätigkeitszeitraum

3/2020 – 7/2020

Tätigkeitsbeschreibung

Implement DocuSign within the SP functionality following IT companies’ requirements on the cloud.

My tasks:

 Prepare Project Charter
 Check that required contracts and licenses are in place
 Define technical approach
 Setup Project team and Project Plan and set clear responsibilities
 Verify that process / templates are established within the Sandbox and tested before implementing on the productive environment
 Check that training material has been established
 Manage the Project and reporting to the Steering Committee
 Verify that all required project documentation is delivered

Eingesetzte Qualifikationen

PRINCE2

Business Development & Program Management
Kundenname anonymisiert, Basel
9/2019 – 5/2020 (9 Monate)
IT & Entwicklung
Tätigkeitszeitraum

9/2019 – 5/2020

Tätigkeitsbeschreibung

Design & implement a qualified multi-cloud managed services for Comos to enable true digital transformation for several industries such as Energy, Pharma, Automotive etc.

My tasks:

 Define strategy for the program to achieve business resilience, security, and compliance
 management with industry-leading SLAs
 Review & approve contracts
 Define technical approach with the different stakeholders and align on multiple options for the cloud (AWS, Azure & Local DC)
 Setup Project team and deliverables for the qualification of the IT Infrastructure
 Verify that all required project documentation is delivered for the qualification
 Define certain processes and functions intended to improve operations and cut expenses
 Creation of marketing material for the GST (Global Sales Training) week
 Holding training sessions with over 200+ sales representatives presenting the solution (Comos as a managed Service – CaamS)
 Creation of templates for account & bid management
 Acting as a SPOC for CaamS

Eingesetzte Qualifikationen

PRINCE2

M&A ERP IT - Project & Transition Management
Kundenname anonymisiert, Basel
2/2019 – 10/2019 (9 Monate)
Life Sciences
Tätigkeitszeitraum

2/2019 – 10/2019

Tätigkeitsbeschreibung

Divestiture of Alcon from Novartis where all IT assets (DC`s, Applications, Operations, Contracts etc.) needed to be transferred.

My tasks:

 Prepare documented evidence of the handover for Day 1 (800+ Applications)
 Set up a change management process
 Implement change controls on the application asset baseline
 Prepare the Project Charter for the Application Transition Workstream
 Establish a process for the migration using common standards (V2V, P2V etc.)
 Ensure templates are established
 Provide training to respective project team members
 Manage Project and reporting to the Steering Committee

Eingesetzte Qualifikationen

PRINCE2

Program Management
Kundenname anonymisiert, Basel
2/2018 – 9/2018 (8 Monate)
Life Sciences
Tätigkeitszeitraum

2/2018 – 9/2018

Tätigkeitsbeschreibung

Provide the required infrastructure resources in time, quality and budget to support and contribute to the success of the Program.

My tasks:

 Manage 5 Project manager working on different programs for delivering high class IT solutions for Development IT
 Support the respective Program leads in any regards related to IT
 Report closely to the NVS leadership teams such as NVS CIO, Head of DIT, Head of TIS
 Manage escalation in time and monitor closely all activities
 Communicate through different channels to all related stakeholders

Eingesetzte Qualifikationen

Enterprise project management (EPM)

Zertifikate

CISA
Februar 2018
ITIL v3
Januar 2014
Prince 2
Januar 2013
CSV Representative
Januar 2011
Novartis ICE Methodology (PM) Certificates (Bronze & Silver)
Januar 2011
Gamp 5 Training certificate
Januar 2008
GxP Training Certificate
Januar 2008

Ausbildung

Informations- und Kommunikationswissenschaften
(Diplom Informationswirt)
Jahr: 2007
Ort: Fachhochschule Köln

Qualifikationen

Advanced knowledge in IT Service Management and Regulatory Compliance, e.g., ITIL, V-Model, CSV, GxP, CFR Part 11, SOX, GAMP 5 with certifications in CISA, CSV representative, ISO 9001:2015 and ISO/IEC 20000-1:2011

Über mich

Dynamic management professional in the IT Service Industry with 10+ years of experience in Business Development, Customer Relationships, and Solution Discovery & Delivery with large and mid-sized Pharmaceutical Corporations. Solid reputation in building high-performing, diverse and empowered teams capable to produce business value and in transforming customers’ business processes leveraging technologies and digital.

A trusted advisor for all levels of management population at Customers including C-suites, and a skilled communicator and influencer capable to bring people with diverse backgrounds and at different management levels together, built consensus and mobilize them towards common goals

Exceptionally reliable and accurate with proven track record of managing extensive workload and consistently delivering to high expectations in demanding and fast-paced global corporations.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Türkisch (Muttersprache)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
246
Alter
42
Berufserfahrung
13 Jahre und 10 Monate (seit 08/2007)
Projektleitung
10 Jahre

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