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.