Position Summary
Director – IT Quality & Compliance provides strategic leadership and governance for IT Quality Management Systems (QMS), Regulatory Compliance and Audit Readiness across Biocon global IT landscape. The role is accountable for establishing and maintaining a risk-based compliance framework that ensures all GxP computerized systems remain compliant with applicable global regulatory requirements, including 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ISO and corporate quality standards.
- Lead a high-performing IT Quality & Compliance teams supporting digital programs.
- Define and implement the strategic vision, roadmap, and Quality framework for Digital IT systems.
- Establish enterprise-wide IT Quality policies, standards, procedures, and governance mechanisms.
- Govern validation strategy of all the digital initiatives for enterprise applications, manufacturing, laboratory & Clinical areas. Ensure compliance during its lifecycle.
- Provide executive approval and oversight of Validation Plans, Requirements Specifications, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports.
- Provide compliance guidance for emerging technologies and modernization programs.
- Lead inspection-readiness programs across all regulated IT systems & act as primary IT Quality representative during Health Authority inspections. Present audit readiness status and compliance metrics to executive leadership.
- Ensure timely closure and effectiveness verification of audit findings, observations, CAPAs, and commitments.
- Oversee Change Controls, Deviations, Incidents, CAPAs, Risk Assessments, and periodic review activities.
- Monitoring of compliance KPIs, quality metrics, audit observations, and management review processes to evaluate the success of operations.
- Ensure effective management of third-party risks impacting regulated systems.
- The incumbent will partner with IT, Quality Assurance, Manufacturing, R&D, and Business Functions to ensure compliance is embedded throughout the system lifecycle while enabling innovation, digital transformation, and operational excellence.
- Partner with business and IT leadership to ensure quality-by-design principles are incorporated into projects.
- Drive a culture of quality, integrity, accountability, and continuous improvement.
- Manage team budgets, resource planning, and capacity allocation to ensure effective delivery of IT Quality & Compliance objectives.
Experience
- Bachelor's / master's degree in engineering, Computer Science, Information Technology, Pharmaceutical Sciences, or related discipline.
- 18–20+ years of experience in IT, Quality Assurance, Computer System Validation, or Regulatory Compliance.
- Minimum 8–10 years in leadership roles managing IT Quality and Compliance functions within regulated industries.
- Extensive experience supporting global regulatory inspections and audits.
- Proven experience in digital transformation, cloud validation, data integrity, and enterprise quality systems.
- Strong knowledge of pharmaceutical, biotechnology, and GxP environments.
Preferred Skills:
- Strategic Thinking
- Executive Communication
- Stakeholder Management
- People Management
- IT Quality
- Audit & Compliance
