Senior SAP QM Functional Consultant | S/4HANA & GxP Specialist

Roy Harris

24 Years of Hands-on SAP QM Leadership across Global Manufacturing & Life Sciences

Delivering mission-critical SAP Quality Management solutions across procurement, manufacturing, and warehouse logistics within global SAP ECC and S/4HANA programmes. Specialist in GxP/CSV compliance, LIMS/MES interfaces, and zero-defect data cutovers.

📍 Location: Newport, United Kingdom
✉️ Email: roy.harris@haricom.co.uk
📞 Phone: +44 7724 606 064
🏛️ Consulting Practice: Haricom Limited ↗
24+
Years of Hands-on SAP QM Experience
5
Full Lifecycle Implementations Delivered
9
Zero-Defect Global Rollouts (Heraeus)
10+
Years in GxP Regulated Life Sciences
Executive Summary

Deep Functional Expertise. Proven Delivery Track Record.

Senior SAP QM Functional Consultant with 24 years of hands-on experience delivering robust SAP QM solutions for global manufacturing organisations across procurement, manufacturing, and warehouse management within SAP ECC and S/4HANA programmes.

Recognised by clients and system integrators for end-to-end process design, GxP/CSV compliance, complex RICEF interfacing (LIMS/MES), and rigorous testing and validation. Specialist in SAP QM master data, inspection processing, non-conformance management, and zero-defect data migrations.

Trusted Partner for High-Stakes Deployments

Successfully led the Inspect to Release stream for BioNTech's S/4HANA 2023 upgrade, managed 9 global template rollouts for Heraeus with zero cutover errors, and authored comprehensive GxP validation suites (unit/SIT/OQ/PQ/UAT) for regulated pharmaceutical leaders.

01

End-to-End Quality Architecture

Expertise covering QM in procurement, warehouse quality (WM/EWM), shop-floor in-process inspection, quality certificates (CoA), and customer/supplier complaints.

02

GxP & Life Sciences Validation

10 years of experience in GxP/CSV environments authoring 100+ page test scripts, executing SIT/OQ/PQ/UAT, and designing validated batch release workflows.

03

Zero-Defect Data Migration

Developed custom ETL validation models replicating SAP business rules before upload, delivering 100% verified cutovers with LTMC and migration tools.

Project Highlights

5 Full Lifecycle Deliveries

Comprehensive leadership spanning Blueprint, Fit-to-Standard, Configuration, Validation, Cutover, and Hypercare across global programmes.

S/4HANA
Full Lifecycle #4

Santen Pharmaceuticals

EMEA & USALife Sciences18 Months (2021–2022)

Delivered SAP QM implementation for Santen EMEA (brownfield ECC 6 to S/4HANA) and USA (greenfield S/4HANA) in GxP. Authored complex 350-page GxP functional design for custom source inspection and executed migration via LTMC.

S/4HANA Greenfield & Brownfield Source Inspection LTMC Migration GxP Validation
SAP R/3 V4.6C
Full Lifecycle #3

Velux Denmark A/S

Denmark & USAManufacturing31 Months (2005–2008)

Reviewed, enhanced, and configured global SAP QM template supporting discrete manufacturing, WM integration, and shop-floor quality. Designed custom solution to record internal production non-conformities and developed SAP Queries for cutover.

Global Template WM Integration Shop-Floor QM Non-Conformities
SAP R/3 V4.6C
Full Lifecycle #2

Sara Lee – Decotrade

SwitzerlandCommodities Trading12 Months (2004–2005)

Delivered extension of the Sara Lee Global template for Coffee trading, including custom QM user exits, inspection processing, vendor/customer complaint notifications, and custom management reporting queries.

Make-to-Demand User Exits Coffee Trading Complaint Mgmt
SAP R/3 V4.6C
Full Lifecycle #1

KLM Royal Dutch Airlines

Amsterdam, NetherlandsAerospace & Defence19 Months (2002–2003)

Configured SAP QM to provide Aerospace & Defence functionality in the engine maintenance process, integrating with MM, CS, and PM during upgrade from V3.1h to 4.6C. Designed and delivered custom Inspector Workbench.

Aerospace & Defence Engine Maintenance Inspector Workbench CS / PM / MM
9 Global Rollouts
Major Rollout Programme

Heraeus (avato / IBM)

Germany, USA, UK, RomaniaPrecious Metals50 Months (2017–2021)

Functional Data Owner & QM Data Migration Lead for 9 global template rollouts. Recovered failing migration stream and created pre-validation toolset resulting in 100% on-time, zero-defect go-lives across all 9 rollouts.

Zero-Defect Cutovers 9 Global Sites ETL Validation Data Migration Lead
Technical & Functional Competencies

Specialist Skill Set

Over two decades of specialised functional excellence spanning SAP QM architecture, integration, compliance, and enablement.

⚙️

SAP QM Competencies

  • Configuration & Solution Architecture
  • QM Master Data (Plans, Characteristics, Sampling)
  • Warehouse Quality (WM & Embedded EWM)
  • Inspection in Procurement & Goods Receipt
  • In-Process & Production Inspection
  • Results Recording & Usage Decision (UD)
  • Quality Notifications (Internal, Supplier, Customer)
  • Certificate of Analysis (CoA) Processing
  • Non-Conformance & Defect Management
🔗

S/4HANA & Integration

  • S/4HANA 2023 & ECC 6.0 Deployments
  • Integration with MM, PP, SD, PM, CS & SCM
  • Embedded EWM Quality Workflows
  • LIMS Integration & Interfacing (IDoc / XML)
  • MES (Manufacturing Execution System) Sync
  • RICEF Specifications & Development Testing
  • Custom Inspector Workbenches & User Exits
  • QM Security Authorisations Redesign
🛡️

GxP, CSV & Compliance

  • 10 Years GxP Regulated Life Sciences
  • Computerised System Validation (CSV)
  • Blueprint & Fit-to-Standard Workshops
  • Validated Batch Release Architecture
  • CAPA Management Notifications
  • Audit Preparation & Pharma Audit Response
  • Stakeholder Alignment (Quality, Ops, Validation)
📊

Data Migration & Cutover

  • End-to-End QM Data Migration Leadership
  • S/4HANA Migration Cockpit (LTMC)
  • Custom Excel ETL Auto-Validation Tools
  • SAP Validation Rules Replication Pre-Upload
  • Multi-Mock Migration Cycles & Defect Fixing
  • 9 Zero-Defect Template Cutovers
📝

Testing & Documentation

  • 100-page GxP Test Script Authoring
  • Unit, SIT, OQ, PQ & UAT Execution
  • Business Process Master List (BPML)
  • 350-page Functional Specifications
  • Change Proposal & Impact Assessments
  • Defect Resolution & Go-Live Hypercare
🎓

Training & Enablement

  • Certified SAP PLM400 Instructor (Rated 6.1/7)
  • SAP Enable Now E-Learning Creation
  • 350 PowerPoint E-Learning Storyboards
  • TTMS Collaboration & Course Review
  • Super-User & Key-User Coaching
  • Multi-Language Cross-Cultural Delivery
Career History

Consulting Experience Timeline

Over two decades of high-impact engagements across multinational enterprises.

Primary SAP Support Engineer (Part-Time)

01/2017 – Present
Rimini Street • United Kingdom (100% Remote) • 11 Contract Extensions Third-Party SAP Support
  • Providing senior-level on-demand SAP QM functional support and defect resolution as part of a global support delivery team.
  • Resolving complex SAP QM functional issues across multiple production customer landscapes in USA and EMEA.

Senior SAP QM Consultant & Team Lead

08/2023 – 09/2025
BioNTech / NTT DATA • Mainz, Germany (100% Remote) • 26 Months (3 Extensions) S/4HANA 2023 Life Sciences
  • Full Lifecycle Delivery #5: Delivered SAP QM leadership for the Inspect to Release stream across 3 major programme releases and upgrade to S/4HANA 2023 in a GxP environment.
  • Configured SAP QM integrated with MM, PP, Embedded EWM, LIMS, and MES; designed IDoc/XML interfaces for validated batch release.
  • Authored 100-page GxP test scripts (unit/SIT/OQ/PQ/UAT) and managed ETL data migration with auto-validating templates.
"Thanks for your great support! I'm very glad to have you on board." — Matthias Baumann, Quality Product Owner, BioNTech

SAP QM E-Learning Documentation Expert

01/2023 – 06/2023
Hitachi Energy • Germany / Switzerland (100% Remote) • 6 Months S/4HANA Discrete Manufacturing
  • Authored and reviewed all SAP QM training documentation in daily collaboration with the Global QM Process Owner.
  • Authored 350 PowerPoint storyboard slides and used SAP Enable Now to record QM transactions for global digital courses.
"I was very impressed with your results." — Kirstin Siefen, Global QM Process Owner, Hitachi Energy

Senior SAP QM Advisor

06/2021 – 11/2022
Santen Pharmaceuticals / Tenthpin • EMEA & USA (100% Remote) • 18 Months S/4HANA Life Sciences (GxP)
  • Full Lifecycle Delivery #4: Delivered SAP QM for Santen EMEA (brownfield ECC to S/4HANA) and USA (greenfield S/4HANA).
  • Authored a 350-page GxP functional design for custom source inspection and automated certificate processing.
  • Executed SIT/OQ/PQ/UAT defect resolution, trained key users, and managed data migration using LTMC.
"I personally want to thank you for all your support... guidance and patience during our long calls and for everything you taught me." — Mariam Rosendo, Director of Quality, Santen InnFocus Plant USA

SAP QM Functional Data Owner & Migration Lead

04/2017 – 06/2021
Heraeus / avato / IBM • Hanau, Germany • 50 Months (4 Extensions) SAP ECC 6.0 9 Global Rollouts
  • Managed and executed end-to-end QM data migration for 9 global template rollouts (Romania, USA, UK, Germany), resulting in zero-defect cutovers.
  • Designed Excel-based workflows replicating SAP validation rules before upload to eliminate referential integrity errors.
  • Collaborated with IBM and external Data Engineering across multiple mock migration cycles and hypercare.
"This is the most error-free QM implementation I have seen." — Richard Ward, VP IT Heraeus Americas

Senior SAP QM Consultant & Global Support Lead

04/2010 – 09/2016
GlaxoSmithKline (GSK) • London, UK • 78 Months (11 Extensions) SAP R/3 & ECC 6 Life Sciences (GxP)
  • Global Lead for 3rd-line QM Support team (7 consultants) across 6 global production systems.
  • Implemented validated changes, CAPA management notifications, authorisation redesign, and rapid audit responses.
"You did a brilliant job bringing our team together, giving direction and getting us back on track... Your immense knowledge will be missed." — Sinead O'Neill, QM Support Consultant, GSK

Earlier SAP QM Consulting & Early Career Roots

1990 – 2010
Multinational Programmes • Global Manufacturing, Aerospace & Trading
  • GKN Aerospace (UK, 2016): Custom workflow for QM notification tasks.
  • Syngenta Seeds (Switzerland, 2009–2010): Global batch classification and QM master data across 46 countries.
  • UCB Pharma (Poland, 2009): Rapid rollout of QM template and validation in Poland.
  • FUJIFILM Europe (Belgium, 2008–2009): Blueprint for 3 chemical batch sites.
  • Siemens Wind Power (Denmark/USA, 2008): Template rollout and QM/WM integration.
  • Velux Denmark (2005–2008) [Lifecycle #3]: Global discrete manufacturing QM template.
  • SAP Belgium (2005): Instructor for PLM400 QM 5-day course (rated 6.1/7).
  • Sara Lee (2004–2005) [Lifecycle #2]: Coffee trading global template extension.
  • KLM Aerospace (2002–2003) [Lifecycle #1]: A&D engine maintenance & Inspector Workbench.
  • Early Career (1990–2001): SCA Hygiene (IBM), BP Germany (Axon), Glaxo Wellcome, Ernst & Young CSI (SAP QM/PM Consultant), Sasol (Chemical Engineer & Analyst).
Client Feedback

Verified Endorsements

Unsolicited feedback from project sponsors, process owners, and delivery partners.

This is the most error-free QM implementation I have seen.

Richard Ward
Vice President Information Technology
Heraeus Americas

All phases of the project went live on time and with very high data quality.

Samira Przybilla
Data Services Lead (Heraeus Magellan)
IBM / Practice Manager

I personally want to thank you for all your support... guidance and patience during our long calls and for everything you taught me.

Mariam Rosendo
Director of Quality
Santen InnFocus Plant (USA)

Thanks for your great support! I'm very glad to have you on board.

Matthias Baumann
Quality Product Owner
BioNTech (S/4HANA)

The business SCM Process Owner is a challenge to deal with, and you did it very well... you created just the right impression.

Simon Flowers
Partner, Integration Manager
Tenthpin Consulting / Santen

I was very impressed with your results.

Kirstin Siefen
Global QM Process Owner
Hitachi Energy

I learned so much from you because you are always willing to help. You kept on surprising all of us how big a knowledge you have of SAP.

Henning Bossen
Internal QM Consultant
Velux A/S, Kolding

Roy is a top-caliber SAP QM Consultant that I hired for our rollout Project in Belgium. I would recommend him unconditionally to others.

Dragan Grujic
Program Manager, PMO
FUJIFILM Europe

You have good 'mensen-kennis' [people-knowledge].

Patrick Gerrits
Functional SAP Application Manager
KLM Royal Dutch Airlines

🎓 Education & Degree

B.Sc. Chemical Engineering
University of Cape Town (UCT), South Africa

🌐 Languages

English (Native)
Afrikaans (Fluent)
Dutch & Flemish (Professional Working)
German (A1 / Basic)
Get In Touch

Let's Discuss Your Next SAP QM / S/4HANA Initiative

Whether you are planning an S/4HANA transformation, require expert leadership for a GxP Life Sciences stream, or need a zero-defect cutover strategy, I am available for advisory, full lifecycle, and support engagements.

✉️
Direct Email
roy.harris@haricom.co.uk
📞
Direct Phone
+44 7724 606 064
📍
Location & Working Mode
Newport, UK (100% Remote / Hybrid)

Professional Profiles & Company

Connect with me directly or explore Haricom Limited's consulting services.

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