Assistant General Manager - Corporate Quality Control

Role & responsibilities

• Lead Corporate QC initiatives for harmonization and standardization of analytical quality systems across manufacturing sites.
• Provide strategic guidance to site QC teams for compliance, analytical excellence, and continuous improvement.
• Review and approve analytical quality documents including:
• Specifications
• Standard Testing Procedures (STPs)
• General Testing Procedures (GTPs)
• Analytical Data Sheets
• Analytical Method Validation and Transfer documents
• Drive Change Control implementation related to analytical specifications, methods, and QC documentation.
• Provide QC oversight for new product development, technology transfer, and product lifecycle management activities.
• Review analytical method validation, method transfer, and verification protocols/reports.
• Monitor and implement global pharmacopeial updates (IP, USP, BP, EP, JP) and ensure regulatory compliance.
• Support and lead regulatory inspections, customer audits, and corporate audits related to QC activities.
• Ensure effective management of QC-related quality systems including OOS/OOT, Deviations, CAPA, Change Control, Risk Assessments, and Data Integrity.
• Review critical investigations and ensure robust root cause analysis and effective CAPA implementation.
• Review and approve QC-related documents including MFC, MPC, PDR, specifications, analytical protocols, and new product documentation.
• Provide oversight for vendor qualification, third-party laboratory audits, and external testing compliance.
• Mentor and develop QC teams while promoting a strong culture of quality and compliance.

Preferred candidate profile

• Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry / Analytical Chemistry / Pharmaceutical Chemistry / Life Sciences).
• Experience: 1220 years of experience in Pharmaceutical Quality Control / Corporate Quality Control / Analytical Quality Assurance.
• Strong experience in managing analytical quality systems at corporate or multi-site level.
• Hands-on experience with global regulatory requirements and inspections (USFDA, EU GMP, MHRA, WHO-GMP, PIC/S).
• Strong knowledge of:
• cGMP & GLP requirements
• ICH Guidelines
• Data Integrity (ALCOA+)
• Analytical Method Validation & Transfer
• OOS/OOT Investigations
• CAPA & Change Control
• Pharmacopeial compliance
• Experience with QC systems such as LIMS, Empower, SAP, ERP, or eQMS will be preferred.
• Excellent leadership, communication, analytical, and stakeholder management skills.