ANI Pharmaceuticals, Inc.
Website:
anipharmaceuticals.com
Job details:
About the Role
The Integration Architect is a key hire within ANI's Digital Architecture function, responsible for designing, governing, and delivering the enterprise integration strategy that connects ANI's core business systems.
The immediate mandate is establishing a robust, scalable, and GxP-compliant integration foundation between SAP ERP and ANI's external trading partner ecosystem — spanning EDI (Electronic Data Interchange) and Order-to-Cash (O2C) processes — built on Microsoft Azure as ANI's core cloud foundation.
This role will define the integration architecture patterns, platform standards, and governance models that underpin ANI's digital operating model as the company scales. The Integration Architect will partner with Enterprise IT, Supply Chain, Finance, and Commercial functions globally to ensure every integration is secure, auditable, and business-enabling.
This is an individual contributor role with integration design authority across all integration domains, reporting directly to the Director of IT.
Responsibilities
1. Integration Strategy & Architecture
- Define and own ANI's enterprise integration architecture strategy, establishing platform standards, patterns (event-driven, API-led, point-to-point, hybrid), and governance on Azure — operating from the Chennai GCC with global applicability.
- Author and maintain Integration Architecture Decision Records (ADRs), pattern libraries, and reference architectures.
- Establish a future-state integration target architecture that supports SAP ERP, B2B/EDI, O2C, and adjacent domain systems across a Microsoft-first cloud foundation.
- Evaluate and recommend Azure integration services (Azure Integration Services, API Management, Service Bus, Logic Apps, Data Factory, Event Grid) appropriate to ANI's regulatory and operational context.
- Ensure all integration designs meet GxP, GAMP 5, 21 CFR Part 11, and ALCOA+ data integrity requirements from the outset.
2. SAP ERP Integration
- Lead the design and delivery of integration between SAP ERP and downstream/upstream systems, establishing clean, validated, and auditable data flows across Finance, Supply Chain, Manufacturing, and Commercial domains.
- Define SAP integration patterns for both real-time (API/event) and batch scenarios, aligned to SAP on Azure architecture best practices and SAP BTP where applicable.
- Establish data mapping standards, error handling frameworks, and operational monitoring for all SAP integration touchpoints.
- Partner with the SAP programme and US-based business stakeholders to ensure integration design is change-ready and can absorb future SAP evolution (S/4HANA migration roadmap consideration).
3. B2B Connectivity & EDI
- Architect and deliver ANI's B2B integration platform, enabling reliable electronic trading partner connectivity for customers, 3PLs, wholesalers, and suppliers across US and global markets.
- Define EDI standards strategy (X12, EDIFACT, AS2, SFTP, API-based B2B) appropriate for pharmaceutical distribution and serialization compliance (DSCSA).
- Establish onboarding frameworks, trading partner SLAs, message validation standards, and exception management processes.
- Ensure B2B integration architecture is audit-ready and supports regulatory traceability requirements for serialized product flows.
4. Order-to-Cash (O2C) Integration Foundation
- Design the integration backbone supporting ANI's O2C process — from customer order receipt through to fulfillment, invoicing, and cash application — ensuring seamless data flow across CRM, ERP, 3PL, and commercial systems.
- Identify O2C integration gaps and define a phased remediation roadmap, prioritizing data accuracy, exception reduction, and cycle time improvement.
- Establish real-time order status visibility capabilities for internal stakeholders and trading partners.
- Partner with US-based Finance and Commercial teams to ensure O2C integration design supports revenue recognition, deduction management, and chargebacks.
5. GxP Compliance, CSV & Data Integrity
- Embed GxP and Computer System Validation (CSV) requirements into all integration design and delivery activities — URS, FS, DS, IQ/OQ/PQ — ensuring no integration goes live without appropriate validation evidence.
- Uphold ALCOA+ principles for electronic data transmitted across integration layers; ensure audit trails are complete, tamper-evident, and inspection-ready.
- Act as the integration subject matter expert in regulatory inspections, internal audits, and quality review boards — collaborating across time zones with US Quality and Regulatory teams.
- Maintain integration validation documentation lifecycle in line with GAMP 5 and ANI change control processes.
6. Azure Integration Platform & Governance
- Define and govern ANI's Azure-based integration platform — establishing provisioning standards, naming conventions, environment strategy (dev/test/prod), and CI/CD pipelines for integration artefacts.
- Establish integration observability standards: centralised logging, alerting, SLA dashboards, and incident response runbooks using Azure Monitor and related tooling.
- Define API governance standards including versioning, security (OAuth 2.0, Entra ID), rate limiting, and API catalogue management via Azure APIM.
- Align all integration platform controls with ANI's Microsoft Defender XDR security posture and Purview data governance framework.
7. Global Cross-Functional Stakeholder Partnership
- Operate as the primary integration architecture partner for Supply Chain, Finance, Commercial, Manufacturing IT, and Quality functions globally — translating business process requirements into technically sound integration designs.
- Collaborate effectively across time zones with US-based stakeholders, adapting availability and communication cadence to support a global operating model.
- Lead integration design authority sessions and participate in the CDA Architecture Review Board, providing integration domain expertise for all ADRs with integration dependencies.
- Communicate integration architecture decisions and risks clearly to both technical teams and senior business stakeholders in the US and India.
- Proactively surface integration dependencies across programmes of work, ensuring no critical initiative is blocked by unresolved integration design questions.
8. Vendor & Partner Management
- Manage relationships with integration platform vendors, SI partners, and trading partner technical contacts — governing SLAs, escalation paths, and roadmap alignment.
- Lead RFI/RFP processes for integration tooling and platform services where required, providing architectural evaluation and recommendation.
- Ensure vendor contracts appropriately cover data handling, audit rights, and GxP obligations.
Skills & Competencies
- Deep enterprise integration architecture expertise with a strong grasp of patterns: event-driven, API-led, pub/sub, orchestration vs. choreography.
- Ability to translate complex integration designs into clear, governance-ready architecture documentation and ARB submissions.
- Strong regulatory mindset — capable of embedding GxP compliance into integration design without sacrificing agility or delivery pace.
- Proven ability to operate effectively in a global working model — collaborating across US and India time zones with business and technology stakeholders.
- Excellent stakeholder communication — equally effective presenting to operations teams and C-suite leadership across geographies.
- Disciplined, data-driven approach to problem-solving; comfortable owning architectural risk decisions.
- Collaborative leadership style with the gravitas to drive cross-functional alignment on integration strategy without direct authority.
Qualifications & Requirements
- Bachelor's degree in Information Technology, Computer Science, Software Engineering, or a related field; advanced degree a plus.
- 7+ years of enterprise integration architecture experience, with at least 3 years in a regulated industry (pharmaceutical, life sciences, or healthcare strongly preferred).
- Demonstrable expertise designing and delivering SAP integration architectures — SAP on Azure, SAP BTP, SAP Integration Suite, or equivalent middleware.
- Proven B2B/EDI platform experience: X12, EDIFACT, AS2; trading partner onboarding at scale in a pharma or distribution context.
- Hands-on Azure integration platform experience: Azure Integration Services, APIM, Service Bus, Logic Apps, Event Grid, or Azure Data Factory.
- Proven GxP compliance credentials: hands-on CSV experience (GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+) in integration or system implementation contexts.
- Experience with O2C process integration across ERP, CRM, 3PL, and commercial platforms.
- Strong API design and governance experience: REST, SOAP, GraphQL, OpenAPI standards, OAuth 2.0 / Entra ID security patterns.
- Experience working in or with a Global Capabilities Center or offshore/nearshore delivery model strongly preferred.
- Microsoft Azure certification (Azure Solutions Architect Expert or Azure Integration Services specialty) preferred.
DSCSA and pharmaceutical serialization integration experience is a significant advantage.
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