Commercial Quality Assurance Operations Lead

Role: Commercial Quality Assurance Operations Lead

Work Experience: 10+ years.

Work location: Mumbai

Mode of work: Hybrid

Job Summary

The Commercial Quality Operations Lead will oversee and manage all quality-related activities within the Pharmaceutical commercial operations of IMS ensuring compliance with regulatory standards and maintaining the highest standards of product quality. This role will drive quality assurance, risk management, and process improvements in commercial supply chain processes.

Key Responsibilities

1. Quality Management Systems (QMS):

• Oversee the development, implementation, and maintenance of QMS to ensure compliance with Good Distribution Practices (GMP) and other regulatory requirements.

• Manage batch release processes, ensuring timely and compliant product releases to market.

• Lead investigations into quality deviations, implement corrective and preventive actions (CAPA), and drive root cause analysis.

2. Regulatory Compliance:

• Ensure adherence to all applicable regulatory standards

• Prepare for and manage regulatory audits and inspections, addressing findings and ensuring follow-up actions.

• Monitor and interpret evolving regulatory requirements to maintain compliance across commercial operations.

3. Leadership and Team Management:

• Lead, mentor and Collaborate with cross-functional teams to align quality objectives with business priorities.

• Drive training programs to ensure team competency in quality and regulatory standards.

4. Risk Management and Process Improvement:

• Identify and mitigate quality risks in commercial operations, including supplier and vendor management.

• Implement process improvements to enhance efficiency, reduce costs, and maintain compliance without compromising quality

5. Stakeholder Engagement:

• Act as the primary quality liaison with external partners, including commercial teams and regulatory authorities.

• Communicate quality metrics, issues, and strategies effectively to senior leadership and cross-functional teams.

• Support product launches by ensuring quality requirements are met for commercial readiness.

6. Metrics and Reporting:

• Develop and monitor key performance indicators (KPIs) to assess the effectiveness of quality operations.

• Provide regular reports on quality performance, audit outcomes, and compliance status to senior management.

Qualifications and Skills

• Education: Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field; advanced degree (e.g., MS, MBA) preferred.

• Experience:

• Minimum of 10 +years of experience in pharmaceutical quality assurance, with at least 3-5 years in a leadership role within commercial operations.

• Proven track record in managing GMP-GDP