Quality Risk Manager

Role Summary:
As a Quality Risk Manager, you will be responsible for establishing, implementing, and maintaining a robust Quality Risk Management (QRM) system across the organization. This role is crucial for identifying, assessing, and mitigating risks associated with product quality, regulatory compliance, and business operations within the biotechnology sector in India. You will ensure that QRM principles are integrated into all relevant processes and decision-making.

Key Responsibilities:
- Develop and implement the company's Quality Risk Management strategy and procedures in alignment with global standards and local regulatory requirements.
- Lead and facilitate risk assessment activities for critical processes, products, and projects, including FMEA, HAZOP, and other relevant methodologies.
- Identify potential quality risks, evaluate their impact and likelihood, and recommend appropriate control measures.
- Monitor the effectiveness of implemented risk mitigation plans and ensure their timely execution.
- Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Quality Control, Regulatory Affairs) to integrate QRM into their daily operations.
- Provide training and guidance to employees on QRM principles and tools.
- Maintain comprehensive documentation of all risk management activities, including risk registers, assessment reports, and mitigation plans.
- Stay updated with evolving regulatory expectations and industry best practices in Quality Risk Management.
- Participate in internal and external audits, providing insights and evidence of the QRM system's effectiveness.
- Report on the status of quality risks and the effectiveness of the QRM program to senior management.