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Corporate Quality Assurance (CQA) – Sr. Executive
- 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.
