SAP Delivery Manager (ERP) Life Sciences Devfi, Inc. 100% remote Salary: DOE
About Devfi
Devfi, Inc is an SAP services partner to life sciences and pharmaceutical companies. We deliver S/4HANA implementations for global pharma manufacturers, CDMOs, biotech and medical device clients across the Globe.
Our clients operate under FDA, EMA and MHRA,GxP oversight. Every system we touch is validated and every change is auditable that standard is why they choose a specialist partner over a generalist.
The role
You will own solution delivery on client engagements: taking a business problem from requirements through solution design, build, validation and deployment, and standing behind the result in production.
This is a hands-on-the-solution role, not a status-reporting one. You will chair design authority, arbitrate between competing designs, decide standard-versus-custom, and hold the line on solution quality when schedule pressure argues otherwise. You'll spend more time in design workshops and defect triage than in commercial negotiation.
Scope spans the S/4HANA core specifications, recipes, formulations, BOMs and change records are regulated data, and how they're versioned and released feeds straight into product registration and batch release.
What you'll do Solution design and build
Own the end-to-end solution across the engagement requirements, fit-gap, functional and technical design, configuration, RICEFW build, integration and cutover.
Chair design authority: adjudicate design decisions, enforce standard-first over custom development, and keep the solution coherent across workstreams rather than locally optimised.
Lead PLM solution delivery specification and recipe management, formulation, BOM and routing lifecycle, engineering change management (ECR/ECO), DMS and product compliance keeping the product data thread intact from R&D through tech transfer into manufacturing and submission.
Design and govern integration across the PLM ERP MES boundary and into LIMS, QMS, WMS and serialisation, including interface specification, error handling and reconciliation.
Own the data agenda: master data design, migration approach, cleansing, load sequencing and reconciliation evidence.
Quality, validation and release
Deliver to GxP requirements CSV, GAMP 5, EU Annex 11, 21 CFR Part 11 with validation strategy and traceability agreed with client QA before build starts, not retrofitted after.
Own the test strategy end to end: unit, SIT, UAT, PQ, regression and performance, with defect triage and release criteria you personally sign off.
Lead cutover, dress rehearsals, go-live and hypercare, with rollback positions agreed in advance.
Stand behind the solution in client audits and regulatory inspections.
Team and delivery discipline
Lead blended teams of Devfi consultants, client staff and offshore resources setting estimation, design review and code review standards.
Run plan, risk, dependency and scope management, and report progress honestly to client sponsors and IT leadership.
Coach consultants and functional leads; contribute reusable design patterns, accelerators and delivery playbooks back into the practice.
What we're looking for Essential
15+ years delivering SAP solutions, 3 of them leading end-to-end delivery as a delivery, solution or programme manager.
Deep functional grounding in S/4HANA across the life sciences modules PP/PP-PI, QM, MM, EWM, SD, PLM. You came up through solution work and can still challenge a design document line by line.
SAP PLM delivery experience specification management, recipe development (SAP RD), DMS, engineering change management, product compliance and how PLM objects flow into the ERP core.
Delivery experience in pharma, biotech, medical devices or another GxP-regulated industry, with a practical grasp of CSV and GAMP 5: you can challenge a validation plan, not just approve one.
Proven ownership of a full lifecycle requirements through hypercare on at least [two] end-to-end implementations.
Integration and data migration experience across a complex application landscape.
Fluency in both V-model and Agile delivery, and the judgement to know which the change and the regulator require.
Stakeholder management to executive level, including the ability to defend a design decision under pressure.
Willingness to travel to client sites or Devfi offices; excellent written and spoken English.
Desirable
SAP Activate, Solution Manager or Cloud ALM; SAP BTP, CPI and integration tooling.
Serialisation and track-and-trace (EU FMD, DSCSA), batch genealogy or electronic batch records.
Integration with MES ([PAS-X, Opcenter]), LIMS ([LabWare, STARLIMS]) or QMS ([Veeva, TrackWise]).
Non-SAP PLM platforms and their SAP interfaces (Teamcenter, ENOVIA, Windchill) or Veeva Vault RIM.
Tech transfer and site-to-site product introduction.
SAP certification in a relevant module; PMP, PRINCE2 or SAFe.
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