Provide corporate-level oversight of quality systems across all manufacturing sites to ensure compliance with global regulatory standards (USFDA, EU-GMP, WHO-GMP, etc.).
Drive implementation and harmonization of GMP practices and quality policies across sites, ensuring alignment with corporate quality objectives.
Review and approve key quality documents such as Master Batch Manufacturing Records (BMRs), Validation Protocols, and SOPs at a corporate governance level.
Lead the Vendor and Supplier Qualification Program – including audits, risk assessments, compliance tracking, and ongoing quality performance monitoring.
Serve as the key quality liaison for external stakeholders – managing quality-related communications and expectations with both clients and regulatory bodies.
Oversee management of critical quality systems including Change Control, Deviation Handling, CAPA, OOS/OOT investigations, and Complaint Management across all sites.
Monitor and assess site-level audit compliance; escalate significant issues to executive management and guide resolution strategies.
Support the preparation and hosting of regulatory inspections and client audits across sites, ensuring consistent corporate representation and follow-up.
Author, review, and maintain Corporate QA SOPs, ensuring alignment with evolving regulatory expectations and industry best practices.
Champion a culture of continuous improvement and compliance, mentoring site QA teams and facilitating quality training initiatives.

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Corporate Quality Assurance (CQA) – Sr. Executive