- Lead all Operations Quality Assurance activities across the manufacturing sites, ensuring compliance, product quality, patient safety, and operations quality performance.

- Accountable for developing and executing the Operations Quality Strategy, translating enterprise quality objectives into measurable site-level priorities/results, driving a culture of quality and compliance, ensuring inspection readiness, and continuously improving quality performance across the sites.

- As the senior Quality leader and designated Quality Management Representative, the Director represents the organization during regulatory inspections/external audits, ensures the effectiveness and compliance of the Quality Management System and partners closely with Operations, R&D;, Regulatory Affairs, Supply Chain, and Business Leadership to ensure product quality, patient safety, and business continuity.

- Ensure all products, manufacturing processes, and quality system activities comply with FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global requirements.

- Lead and represent the sites during FDA inspections, Notified Body audits, customer audits, and regulatory authority interactions,



maintaining a continuous state of inspection readiness.

- Drive timely resolution of audit findings, compliance gaps, nonconformances, and CAPA activities through robust root cause analysis and sustainable corrective actions.

- Provide leadership for Manufacturing Quality, Quality Systems, CAPA, Nonconformance Management, Validation Quality Oversight.

- Establish and monitor quality metrics and management review processes to identify risks, improve performance, and ensure quality system effectiveness.

- Drive a robust culture of quality, compliance, accountability, continuous improvement, and operational excellence throughout the organization.

- Partner with Operations and cross-functional leadership to proactively identify and mitigate quality risks while supporting business growth and product realization.

- Lead quality transformation, remediation, and continuous improvement initiatives to strengthen compliance, process capability, and customer satisfaction.

- Build and develop a high-performing Quality organization through talent management, succession planning, coaching, and organizational development.

📌 Director of Quality Assurance (Pune)
🏢 WhiteSlips Job Management Consultants
📍 Pune