The Associate Director, Supplier Quality Management (SQM) will be responsible for all quality aspects related to external suppliers, contract manufacturers, and service providers supporting GMP operations. This role ensures compliance with company policies, procedures, and global regulatory expectations while safeguarding product quality, patient safety, and data integrity. The position will lead supplier quality oversight, manage supplier-related IT systems, and provide leadership to a team of Supplier Quality professionals within Global Quality Shared Services supporting global Sites.:
As part of the global Quality Assurance organization, the Associate Director SQM will be responsible for:
- Supplier Quality Oversight: Managing the Approved Supplier List (ASL), ensuring suppliers meet GMP and regulatory requirements.:
- Supplier Change Management: Acting as SME for supplier change notifications, evaluating impact, and ensuring proper approvals.:
- SCAR & CAPA Management: Leading supplier corrective and preventive actions, ensuring timely closure and effectiveness verification.:
- Audits & Inspections: Planning, leading, and supporting supplier audits, regulatory inspections, and follow-up actions.:
- SQMS IT Systems: Overseeing Supplier Quality Management Systems (SQMS), ensuring validated status, compliance, and effective use.:
- Global Stakeholder Management: Collaborating with stakeholders across global manufacturing sites, suppliers, and regulatory bodies to align quality expectations and ensure compliance.:
- Risk Management: Implementing risk-based approaches for supplier qualification, monitoring, and escalation of compliance risks.:
- People Management: Leading, coaching, and developing a team of Supplier Quality professionals to ensure operational excellence.:
- Continuous Improvement: Driving innovation, efficiency, and GMP awareness in supplier quality processes.:
Key Responsibilities:
- Ensure suppliers are qualified, monitored, and maintained in compl
📌 Associate Director Quality Assurance (Pune)
🏢 Msd
📍 Pune