Senior Manager - QeC

Job Description

JOB OVERVIEW: We are looking for an experienced and motivated IT Compliance Manager with expertise in SAP S/4 HANA implementation with manage IT compliance activities, ensuring systems and processes adhere to regulatory standards and organizational policies. The ideal candidate will play a key role in implementing and monitoring compliance controls, working closely with cross-functional teams to maintain a secure and compliant SAP S/4 HANA environment. KEY STAKEHOLDERS: INTERNAL Business - Site / Central Partner functions IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis) KEY STAKEHOLDERS: EXTERNAL IT Vendors IT Contractors/Consultants REPORTING STRUCTURE: Reporting to Associate General Manager - QeC/CSV EXPERIENCE: Hands-on experience with IT compliance, quality management, and SAP systems, with a strong focus on SAP S/4HANA. 9+ years of experience in SAP S/4 HANA implementation and configuration. SKILLS AND COMPETENCIES Comprehensive understanding of SAP S/4 HANA architecture, modules, and functionalities. To have in depth understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry - DI, ALCOA+, Part 11, Annex 11, GAMP 5 etc. Knowledge and Experience of Pharma domain -Quality (QA, QC) (Good to have) Knowledge and experience on handling of CSV project related QMS e.g. Change control, deviation, CAPA and incidents. KEY ROLES & RESPONSIBILITIES To have good understanding and knowledge on SAP S/4 HANA application functionalities. Proven track record of successfully delivering multiple full life-cycle SAP S4 HANA implementation projects. Proficiency in managing integrations with other ERP systems or third-party applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC) as per GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To define validation strategy and review CSV deliverables for IT projects for the applications SAP ECC, SAP S4 HANA, etc. To Review and approval of QMS documents e.g. Change control, Deviation, Incidents, CAPA, Extension, etc. as applicable. To ensure infrastructure (Network, Servers, Cloud, Database) are qualified as per required Quality Standards and required documents are in place. To support the initiatives undertaken by Quality e-Compliance team across the Central/PPL sites. To guide Central and Site IT teams for CSV, Data Integrity (DI), and Regulatory Compliance activities. To ensure 21 CFR Part 11, EU Annex 11 and GAMP 5 compliance across PPL sites, as applicable. To coordinate & build good working relations with Site/business users, Subject Matter Experts (SMEs) and IT operations team, Manage vendors / partners / support teams. QUALIFICATION: Graduate in Science/Pharmacy/Engineering Post Graduation - Science/MBA (Desirable)