Senior Executive/Assistant Manager - US QA

Job Title: Sr. Executive / Assistant Manager – US QA Experience: 7–12 Years Qualification: <M.Sc> / M.Pharm Job Purpose To provide Quality Assurance support to US-based manufacturing and quality operations , ensuring compliance with global cGMP, ICH, and regulatory requirements , with a strong focus on biosimilars . The role supports batch release, quality systems, validation, and continuous improvement initiatives in collaboration with global cross-functional teams. Key Responsibilities US QA & Compliance · Provide QA oversight and support to US-based manufacturing and quality operations. · Ensure compliance with global cGMP, ICH, FDA , and applicable regulatory guidelines across QA activities. · Review and approve Batch Manufacturing Records (BMRs) and Certificates of Analysis (CoAs) . Quality Systems & Investigations · Support and review deviation investigations, CAPAs, and change control activities; ensure timely closure in line with internal SOPs. · Participate in risk assessments , root cause analysis , and continuous improvement initiatives . · Contribute to the global harmonization of quality systems and SOPs . Validation, Tech Transfer & Documentation · Provide QA guidance for technology transfers , process validation , qualification , and process improvement initiatives . · Review and approve SOPs, validation protocols, qualification documents , and other technical documentation. · Maintain electronic and paper-based documentation in compliance with ALCOA+ data integrity principles . Quality Metrics & Reporting · Monitor and track key quality metrics and KPIs. · Prepare and present periodic quality reports for US leadership and stakeholders . Cross-Functional Collaboration · Collaborate closely with Manufacturing, Quality Control, Regulatory Affairs, and R&D teams to ensure consistent quality standards. · Support regulatory inspections, audits, and responses as required for US operations. Qualification: · <M.Sc> / M.Pharm (Mandatory) Experience: · 7–12 years of QA experience in biologics / biosimilars Technical Skills · Strong knowledge of cGMP, ICH, FDA regulations , and global quality standards · Hands-on experience in BMR & CoA review and approval · Expertise in deviations, CAPA, change control, and quality investigations · Experience in biosimilars manufacturing, validation, and tech transfer · Sound understanding of data integrity (ALCOA+) principles