Key Responsibilities: • Develop and align quality strategies across plant locations ensuring compliance and product consistency. • Oversee QA/QC with adherence to GMP and global regulatory requirements. • Lead audits, inspections, and regulatory interactions. • Drive continuous improvement using Six Sigma, Lean, and other QMS frameworks. • Build and mentor strong quality teams across sites. • Track and analyze Quality KPIs (FPY, supplier defects, COPQ, regulatory observations). • Collaborate with Plant Heads, Production, R&D, Supply Chain, and Regulatory Affairs for synchronized quality efforts. Required Qualifications: • Bachelor’s/Master’s in Pharmacy, Chemistry, Engineering, or related sciences with 15–20 years of experience in senior QA/QC roles (preferably pharma/regulatory industries). • Strong knowledge of GMP, ISO, FDA, and global regulatory standards. • Proven leadership in multi-site environments with successful regulatory audit experience. Essential Skills: • Multi-site operations & quality systems management • Regulatory compliance leadership • Data-driven problem solving & process optimization • Strong leadership, training, and cross-functional collaboration This role is critical for ensuring consistent quality and operational excellence across multiple facilities, supporting both internal standards and global regulatory demands.
