PUNE · FULLTIME
Director of Quality Assurance
WhiteSlips Job Management Consultants
Pune · onsite · Posted 12d ago
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Section · 01
About this role
- 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 strong 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.
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Section · 02
Skills
validationEU MDRISO 13485Quality Management SystemCAPAIso 14971Non-conformance ManagementFDA regulationsQuality oversightMDSAP