Head of Quality Assurance Operations

About the role

The Head of Quality Assurance Operations leads the QA function at Sanofi's Goa manufacturing site, ensuring that all pharmaceutical products meet global quality standards and regulatory requirements. This senior position drives quality strategy, oversees a high‑performing team, and embeds a culture of continuous improvement across the operation.

Key responsibilities

• Conduct batch reviews and prepare product disposition for intermediates and finished goods, maintaining final accountability in line with Qualified Person (QP) or equivalent.
• Ensure site readiness for national and international regulatory inspections and lead audit support activities.
• Develop and implement annual QA objectives, procedures, and risk‑management processes aligned with corporate strategy.
• Oversee manufacturing processes, validation activities, and SOP compliance; support product transfers and new product qualification.
• Track and close quality events such as deviations, CAPAs, and change controls promptly.
• Establish metrics, monitor KPIs, and drive continuous‑improvement initiatives to enhance QA efficiency.
• Evaluate and recommend new technologies, tools, and methods for quality assurance.

Required profile

• Proven leadership experience in pharmaceutical quality assurance or a related manufacturing environment.
• Strong knowledge of global regulatory frameworks and inspection readiness.
• Demonstrated ability to develop and execute quality strategies and manage cross‑functional teams.
• Excellent analytical mindset with a focus on risk identification and mitigation.

Required skills

• Batch review and product disposition
• Regulatory compliance and inspection readiness
• CAPA and change‑control management
• Process validation and SOP adherence
• Risk management and quality‑systems implementation
• Performance monitoring and KPI reporting