Head of Qualification Support, Lonza Capability Center (LCC), Hyderabad

Lonza • India

Relocation

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AI Summary

Lead qualification, validation, and computerized systems compliance strategies for global cGMP pharmaceutical manufacturing operations. Oversee end-to-end CQV lifecycles, regulatory compliance, and data integrity practices across international sites. Requires 10+ years of QA experience in regulated environments and strong matrix leadership skills.

Key Highlights

cGMP compliance leadership for equipment, facilities, utilities, and computerized systems

team leadership of ≥15 FTE QA professionals across multiple disciplines

global harmonization of engineering and quality standards

regulatory mastery of FDA, Swissmedic, EMA, ICH, PIC/S, EU, and US standards

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Key Responsibilities

Maintain overall accountability for qualification and validation compliance across equipment, facilities, utilities, and computerized systems for cGMP pharmaceutical manufacturing

Direct, enable, and mentor multidisciplinary QA C&Q teams (≥15 FTEs covering Equipment, CSV, Facilities/Utilities, and Enabling Qualification) to achieve consistent high performance

Oversee complete commissioning and qualification (C&Q) lifecycles—from initial qualification through routine operations, periodic reviews, and decommissioning

Serve as senior Global QA representative for LCC Quality in global/cross-functional forums to define and harmonize global engineering and quality standards

Translate evolving global regulatory guidance (e.g., FDA, Swissmedic, EMA) and inspection outcomes into actionable quality strategies and continuous inspection readiness

Evaluate and strengthen data integrity practices, driving standardized processes and continuous improvement initiatives across qualification lifecycles

Partner closely with Global & Site Engineering Leads, LCC Quality Leadership, and site QA teams to ensure seamless project execution and alignment

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Technical Skills Required

cGMP compliance validation lifecycle management data integrity regulatory standards (FDA, EMA, ICH, PIC/S) matrix leadership

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Benefits & Perks

agile career and dynamic working culture

inclusive and ethical workplace

performance-based compensation

global benefits package

Job Description

India, HyderabadThe actual location of this job is in Hyderabad, India . Relocation assistance is available for eligible candidates and their families, if needed.Lead and shape the qualification, validation, and computerized systems compliance strategies for global cGMP pharmaceutical manufacturing operations from the Lonza Capability Center (LCC) in Hyderabad . In this high-impact executive role, you will lead a dedicated team of QA professionals, drive compliance across international regulatory standards, and elevate global quality engineering practices .

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