Senior Executive/Assistant Manager - US QA

Pune, Maharashtra, India

8 - 11 Years

Permanent (ENZBIO)

Job Description

Job Title: Sr. Executive / Assistant Manager US QAExperience: 712 YearsQualification: M.Sc / M.PharmJob PurposeTo provide QualityAssurance 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 incollaboration with global cross-functional teams.

KeyResponsibilitiesUS QA &ComplianceProvide QA oversight and support to US-based manufacturingand quality operations.Ensure compliance with global cGMP, ICH, FDA , and applicable regulatoryguidelines across QA activities.Review and approve Batch Manufacturing Records (BMRs) and Certificatesof Analysis (CoAs) .QualitySystems & InvestigationsSupport 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 continuousimprovement initiatives .Contribute to the global harmonization of quality systems and SOPs .Provide QA guidance for technology transfers , processvalidation , qualification , and process improvement initiatives .Review and approve SOPs, validation protocols, qualification documents ,and other technical documentation.Maintain electronic and paper-based documentation incompliance with ALCOA+ data integrity principles .QualityMetrics & ReportingMonitor and track key quality metrics and KPIs.Prepare and present periodic quality reports for US leadershipand stakeholders .Collaborate closely with Manufacturing, Quality Control, Regulatory Affairs, and R&D teams to ensure consistent quality standards.Support regulatory inspections, audits, and responses as requiredfor US operations.Qualification:Experience:712 years of QA experience in biologics / biosimilarsTechnicalSkillsStrong knowledge of cGMP, ICH, FDA regulations , and global qualitystandardsHands-on experience in BMR & CoA review and approvalExpertise in deviations, CAPA, change control, and quality investigationsExperience in biosimilars manufacturing, validation, and tech transferSound understanding of data integrity (ALCOA+) principles .