Job Description

Purpose of the Job.

We are seeking an experienced and strategic quality leader to lead Global Quality Compliance initiatives across our API manufacturing and R&D; network. The role is responsible for ensuring a robust Quality Management System (QMS), regulatory compliance, inspection readiness, quality risk management, and continuous improvement across multiple manufacturing sites globally.

The incumbent will partner with Site Quality, Manufacturing, R&D;, Regulatory Affairs, Supply Chain, and other cross-functional teams to strengthen quality culture, compliance governance, operational excellence, and regulatory preparedness while driving sustainable business performance.

Key Responsibilities

Global Compliance Governance

- Ensure effective implementation, maintenance, and continuous improvement of the Quality Management System (QMS) across all manufacturing sites and R&D; centers.
- Drive adherence to global quality policies, procedures, and regulatory requirements.
- Establish governance mechanisms to monitor compliance performance and quality metrics.

Inspection Readiness & Regulatory Excellence

- Lead and support site inspection readiness programs for global regulatory inspections and customer audits.
- Provide strategic guidance during inspections, including preparation, inspection management, response development, and post-inspection remediation activities.
- Review and support health authority and customer notifications related to quality and compliance matters.

Quality Risk Management

- Drive implementation of risk-based quality management practices across the network.
- Facilitate identification, assessment, mitigation, communication,



and review of quality risks impacting product quality, compliance, and business continuity.
- Escalate critical compliance risks and provide recommendations for mitigation and corrective actions.

Quality Systems & Continuous Improvement

- Support complex investigations and ensure robust root cause analysis and CAPA effectiveness.
- Review site quality performance metrics and partner with site leadership to establish Quality Improvement Plans (QIPs).
- Lead initiatives focused on deviation reduction, data integrity enhancement, investigation excellence, and compliance transformation.

Audit & Compliance Oversight

- Oversee self-inspection programs, mock audits, and compliance assessments.
- Conduct quality walkthroughs and compliance reviews at manufacturing and laboratory facilities.
- Ensure effective closure of audit observations and regulatory commitments.

Stakeholder Management & Leadership

- Collaborate with Quality, Manufacturing, Regulatory Affairs, Supply Chain, and R&D; leaders across the organization.
- Foster a culture of quality, compliance, and continuous improvement.
- Promote best-practice sharing and harmonization of quality processes across global sites.

Capability Building

- Deliver training and coaching on quality systems, investigations, risk management, inspection readiness, and regulatory compliance.
- Develop organizational capability through mentoring and knowledge-sharing programs.

Strategic Projects

- Lead and support global compliance projects aimed at improving product quality, patient safety, operational excellence, and regulatory compliance.
- Drive implementation of global quality initiatives across manufacturing sites.

📌 Director Global Quality Compliance (Mumbai)
🏢 Tapi
📍 Mumbai