Senior Executive – Development Quality Assurance (DQA)

About the role

The Senior Executive – DQA will lead quality strategy and implementation across biopharmaceutical development, ensuring compliance with domestic and global regulatory requirements.

Key responsibilities

• Develop and execute quality strategies aligned with organizational goals and regulatory standards.
• Integrate quality principles throughout all stages of product development and support technology transfer to GMP sites.
• Maintain effective Quality Management Systems (QMS) and oversee document control for developmental activities.
• Provide QA expertise to cross‑functional teams, conduct internal audits, and drive CAPA initiatives.
• Support regulatory submissions, inspections, and ensure adherence to FDA, EMA, CDSCO, and ICH requirements.

Required profile

• Master’s degree in Pharmacy, Life Sciences, Biotechnology, Biochemistry or related field.
• 6–8 years of experience in the biotechnology industry, with at least 3 years in a QA role focused on product development stages.

Required skills

• In‑depth knowledge of global regulatory frameworks (CDSCO, ICH, FDA, EMA).
• Experience with process characterization, product characterization, biosimilarity studies, and method development/validation.
• Proficiency in establishing and maintaining Quality Management Systems (QMS) for development projects.