Head of Quality Assurance Operation

Job Title- Head of Quality Assurance Operations

Location- Goa

About Our Team

The Quality Assurance Operation team at Sanofi Goa is committed to implementing quality assurance activities in full adherence to global quality standards and HSE guidelines. Through the optimum utilization of resources, our team ensures the consistent delivery of high-quality pharmaceutical products that meet customer requirements — all while upholding the Group's Values and Code of Ethics.

Position Overview

The Head of Quality Assurance Operation is a leadership role responsible for overseeing all quality assurance activities within the Goa manufacturing site. The candidate will develop and drive quality strategies aligned with organizational objectives, lead a high-performing QA team, ensure regulatory compliance, and foster a culture of continuous improvement across the operation

Key Responsibilities

Batch Review & Product Disposition

• Conduct batch reviews and prepare batch dispositions for all intermediates and finished goods manufactured within the designated area
• Ensure final accountability is maintained in alignment with the Qualified Person (QP), Pharmacien Délégué, or equivalent, as required by local regulations

Regulatory Compliance & Inspection Readiness

• Ensure site readiness for inspections by national and international regulatory agencies
• Implement area-specific regulatory requirements and maintain up-to-date compliance with applicable standards
• Lead and support regulatory audits as required

Quality Systems & Risk Management

• Develop and implement annual quality assurance operation objectives in alignment with organizational strategy, vision, and goals
• Develop and implement quality operation procedures to support effective manufacturing activities
• Maintain a robust system to ensure compliance and quality risks are properly identified, tracked, and mitigated
• Ensure timely closure of quality events including deviations, CAPAs, and change controls to maintain compliance and operational efficiency

Manufacturing Oversight & Validation

• Oversee the entire manufacturing process to ensure all steps are validated and adhere to Standard Operating Procedures (SOPs)
• Support product transfers and coordinate new product transfer, qualification, and validation activities
• Serve as the quality focal point for studies related to product hold time, equipment hold time, and campaign length

Performance Monitoring & Continuous Improvement

• Establish metrics and monitor data for quality assurance operation activities to identify trends, issues, and implement action plans
• Establish and monitor Key Performance Indicators (KPIs) and report on the performance and effectiveness of quality assurance operations
• Identify and drive continuous improvement initiatives to enhance QA efficiency and effectiveness
• Evaluate and recommend new technologies, tools, and methods to improve quality assurance processes and outcomes
• Participate in OpEx initiatives and support operational excellence across the site

Other Quality Functions

• Manage Nitrosamine assessments and reviews
• Manage ICH Q3D elemental impurity requirements
• Review calibration documents for Engineering, QC, and PMTD departments
• Manage user access, conduct audit trail reviews, and ensure data integrity compliance

Leadership & Team Management

• Lead, manage, and develop the quality assurance operation team, including hiring, training, coaching, and performance evaluation
• Promote a strong culture of quality and accountability within the QA organization
• Lead management reviews to assess the effectiveness of quality assurance operations
• Participate in intra- and inter-departmental meetings and discussions
• Coordinate with other departments for day-to-day quality-related activities

Required Technical Skills

• Analytical Thinking: Ability to analyze complex data and identify trends, issues, and effective solutions
• Attention to Detail: High level of accuracy in all quality assurance activities
• Communication: Strong verbal and written communication skills for effective interaction with team members, stakeholders, and regulatory bodies
• Problem Solving: Proficiency in identifying problems and implementing effective corrective and preventive actions
• Project Management: Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards

Health, Safety & Environment (HSE)

At Sanofi, the safety of our people and the protection of the environment are non-negotiable priorities. The Head of Quality Assurance Operation is expected to:

• Adhere to all health, safety, and environmental requirements as defined by company policies and procedures
• Ensure the effective implementation of HSE systems and safe working conditions across the team
• Maintain and promote a culture of continuous improvement in health, safety, and environmental practices

Languages: English, Hindi, Konkani, Marathi

Qualification: B.Pharm/M.Pharm

Qualification: More than 8 years of experience