Chief Manager - Quality eCompliance

Job Description

We are seeking a seasoned Quality e-Compliance Manager with extensive expertise in SAP S/4HANA to lead and enhance quality and compliance functions within our organization. The ideal candidate will leverage their 14+ years of experience to drive end-to-end compliance processes, ensuring adherence to industry regulations, and optimizing SAP S/4HANA functionalities to maintain a robust and efficient quality management system. 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 : Head QeC EXPERIENCE: 14+ years of experience in IT compliance, quality management, and SAP systems, with a strong focus and knowledge about SAP S/4HANA implementation and compliance. Proven track record of leading compliance and quality initiatives in a regulated industry (e.g., pharmaceutical, life sciences, manufacturing). SKILLS & COMPETENCY: Deep understanding of SAP S/4HANA modules, especially QM, MM, PP, and WM. Expertise in validation lifecycle management and system validation documentation. Strong knowledge of GxP, 21 CFR Part 11, and other regulatory guidelines. Experience in conducting audits and managing CAPA processes. Proficiency in project management methodologies and tools (e.g., Agile, PMP, Prince2). Excellent analytical, communication, and leadership skills. KEY ROLES & RESPONSIBILITIES: Develop, implement, and monitor quality compliance frameworks for IT systems, with a focus on SAP S/4HANA. Lead the digital transformation of quality processes, leveraging S/4HANA and other enterprise solutions. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC) as per GAMP5, 21 CFR Part 11/EU Annex 11 and Data integrity requirements. Lead system validation activities, including User Acceptance Testing (UAT), IQ/OQ/PQ, and system documentation. Act as a subject matter expert (SME) for SAP S/4HANA in regulatory audits and compliance discussions. Conduct internal audits and support external audits related to IT systems and quality processes. Manage non-conformance issues, CAPAs, deviations, and change controls effectively. Oversee the integration and optimization of SAP S/4HANA modules, ensuring alignment with quality and compliance requirements. To Collaborate with IT departments to address technical issues, system integrations, and infrastructure requirements. Proactive approach to problem-solving and suggest process improvements in Business Processes. To track project performance periodically to ensure both short-term and long-term goals are met Establish and maintain effective relationships with business team, project stakeholders, SAP vendors, consultants, and external partners to leverage expertise and resources as needed. Identify, assess, and mitigate risks associated with IT systems and compliance processes. Ready to travel for project related work within India or outside of India. QUALIFICATION: Graduate in Science/Pharmacy/Engineering Post Graduation Science/MBA (Desirable)