Site Quality Head - OSD

Key Responsibilities

- Lead the overall Site Quality function covering QA, QC, Regulatory Affairs, Analytical Services (ASU), Validation and Compliance, ensuring strong cGMP and Quality Management System (QMS) standards.

- Ensure product quality and batch release by overseeing deviations, OOS/OOT, CAPA, change controls, complaints, recalls, risk management, validation, data integrity and stability programs.

- Drive global regulatory compliance and inspection readiness across USFDA, EU, UK, WHO, PIC/S and other international markets; lead regulatory inspections, customer audits and ensure effective closure of observations.

- Oversee Regulatory Affairs activities, including regulatory submissions, variations, responses to agency queries and implementation of evolving global regulatory requirements.

- Provide strategic oversight of QC & Analytical Services (ASU) including analytical testing, method validation/transfer, stability, laboratory compliance, LIMS and data integrity, while ensuring customer and regulatory requirements are met.

- Lead and develop a large, multi-disciplinary Quality team, building a strong quality culture, defining KPIs, developing talent and ensuring effective succession planning.

- Partner with Site Leadership, global customers and business teams to balance compliance and business requirements, support new product introductions/technology transfers, drive operational excellence and maintain a state of continuous inspection readiness.