About this role
Global Quality Compliance Professional
Location: Hyderabad
Be part of Lonza’s world-class Quality and Regulatory team. As a Global Quality Compliance Professional, you will support Lonza’s strategy to maintain its license to operate by reducing quality and compliance risks across our global supply chain. You will play a vital role in our Global Capability Center (CCG), executing remote, risk-based supplier assessments and oversight activities to ensure the uninterrupted supply of high-quality materials and services for life-changing therapies.
What you will get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Global exposure and the opportunity to work collaboratively across global quality workstreams.
Comprehensive benefits package including medical insurance and wellness programs.
What you will do
Supplier Assessment Management: Execute remote, questionnaire-based supplier quality assessments and desk-based audits in accordance with the annual audit plan; act as the lead or co-assessor to identify compliance gaps.
Risk-Based Program Design: Develop and maintain risk-based audit questionnaires and programs, incorporating regulatory trends, stakeholder inputs, and prior audit insights to ensure robust evaluation of supplier capabilities.
CAPA & Remediation: Evaluate the adequacy of proposed CAPA and remediation plans arising from assessment findings; provide expert guidance to sites and suppliers to ensure alignment with Lonza standards.
Internal Compliance Support: Assist in the planning and execution of questionnaire-based internal assessments for Lonza sites, focusing on desk-based evaluations of site responses to ensure global compliance.
Performance Monitoring: Maintain audit documentation and tracking systems to monitor supplier performance, including risk ranking, KPI management, and trend analysis of complaints or deviations.
Inspection Readiness: Support global sites during regulatory inspections by performing targeted pre-inspection questionnaire assessments and identifying potential compliance gaps.
Regulatory Intelligence: Analyze external regulatory intelligence (e.g., Warning Letters, health authority trends) to refine assessment focus areas and prevent systemic compliance risks.
Project Leadership: Lead or participate in global projects aimed at enhancing digital assessment platforms and standardizing questionnaire templates and assessment frameworks.
Stakeholder Collaboration: Act as the Single Point of Contact (SPOC) for assigned global suppliers, coordinating communication and fostering a strong quality culture across the global organization.
What we are looking for
Experience: Significant experience in Quality Assurance, Quality Compliance, or Auditing within a GMP-regulated Pharmaceutical or Biotech environment.
Technical Knowledge: Deep understanding of GMP regulations (FDA, EMA, etc.) and Quality Risk Management (QRM) principles; experience in supplier qualification and remote auditing practices is highly desirable.
Education: Degree in Life Sciences, Chemistry, Pharmacy, or a related technical field.
Analytical Skills: Strong ability to perform critical reviews of technical documentation and identify subtle compliance risks or inconsistencies.
Software Proficiency: Comfortable using digital audit management tools, tracking systems, and standard Microsoft Office applications.
Communication: Business fluency in English with excellent report-writing skills and the ability to provide constructive feedback to global stakeholders.
Mindset: A detail-oriented professional with a strong quality mindset who can work independently while managing a global portfolio of suppliers.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion, and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
About Lonza
Swiss contract development and manufacturing organization (CDMO) providing biologics, cell, and gene therapy production services.
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