Corporate Quality Assurance (CQA) – Sr. Executive / Assistant Manager

Key Responsibilities:

• Provide corporate-level strategic oversight of quality systems across manufacturing sites, ensuring compliance with USFDA, EU-GMP, WHO-GMP and other global standards.

• Drive implementational and harmonization of GMP practices, quality policies, and procedures across all sites.

• Review and approve critical documents such as BMRs, Validation Protocols, and SOPs.

• Lead Vendor & Supplier Qualification Programs, including audits, risk assessments, and performance monitoring.

• Act as a key quality interface for clients and regulatory authorities.

• Oversee quality management systems such as Change Control, Deviations, CAPA, OOS/OOT investigations, and Complaint Management across all sites.

• Monitor audit outcomes and site-level compliance; escalate critical issues to senior management and support resolution strategies.

• Support regulatory inspections and client audits, ensuring consistent corporate representation and effective follow-up actions.

• Develop and maintain Corporate QA SOPs in line with evolving regulations.

• Drive a culture of quality excellence and continuous improvement, including team mentoring and training initiatives.

Preferred Candidate Profile:

• 7–10 years of experience in QA / CQA / Quality Systems in API pharma industry

• Strong understanding / knowledge of global regulatory requirements

• Exposure to audits, inspections, and site quality oversight

• Excellent communication and stakeholder management skills

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