Solution Architect - SAP Manufacturing Systems

We're Hiring | Solution Architect - SAP Manufacturing Systems

Location: Hyderabad, India

Our client, a US-based Pharma organization, is establishing its Global Capability Center (GCC) in Hyderabad. We are seeking a strategic and technically strong Solution Architect, SAP Manufacturing Systems for Cell Therapy & GMP Compliance. Pharma domain experience is mandatory.

The primary focus of this role is to lead the design, implementation, and optimization of SAP solutions for cell and gene therapy operations. You will act as a cross-functional leader and trusted advisor, ensuring regulatory compliance, end-to-end visibility, and patient-centric operational excellence across clinical and commercial cell therapy supply chains.

Key Responsibilities:

- Serve as the Solution Architect for cell therapy manufacturing across SAP modules (PP-PI, QM, MM, WM/EWM), ensuring compliance with GMP/GxP and 21 CFR Part 11.

- Oversee SAP configuration and development, ensuring scalability and traceability for clinical and commercial advanced therapies.

- Collaborate with Manufacturing, Quality, IT, Regulatory, and Clinical Operations to define business requirements and translate them into validated SAP solutions.

- Drive integration with adjacent systems: MES (e.g., Tulip, Werum PAS-X), LIMS, serialization platforms (SAP ATTP), patient scheduling, and cold chain logistics.

- Lead system validation, audit readiness, SOP development, and change management aligned with GMP and global regulations (FDA, EMA, ICH).

- Act as SME during internal audits, regulatory inspections, and quality system assessments.

- Support continuous improvement initiatives within digital supply chain and IT/OT domains.

Requirements:

- Bachelor's or Master's in Engineering, Life Sciences, Information Systems, or related field.

- SAP experience in life sciences, including manufacturing or supply chain in GMP-regulated environments.

- Pharma domain experience is mandatory.

- Expertise in SAP PP-PI, QM, MM, and integration with production execution/serialization systems.

- Deep understanding of cell therapy manufacturing operations (autologous/allogeneic workflows, scheduling, chain-of-identity controls).

- Experience in validated environments under GAMP5, Annex 11, 21 CFR Part 11, and data integrity standards.

- Experience with SAP S/4HANA, including PP-DS, ATTP, or EWM.

- Familiarity with cell therapy scheduling platforms, clinical supply chain integration, or patient engagement platforms.

- SAP certification is a plus.

- Agile or hybrid project methodology experience.

- Strong interpersonal skills, integrity, and a growth/entrepreneurial mindset.