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 solid 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

📌 Senior Executive/Assistant Manager - US QA (Pune)
🏢 Enzene
📍 Pune