Head of Quality Systems Office

Job Title: Head of Quality Systems Office

Location: Hyderabad, India (Hybrid)

***Relocation assistance is available for eligible candidates and their families, if needed.

 Job Summary:

The Head, Systems Office is responsible for leading the global administration, governance, and continuous improvement of Quality Systems, including Document Management Systems (DMS), Cornerstone Learning Management System (LMS), TrackWise, and gLIMS. This role ensures compliant, efficient, and standardized system operations while maintaining data integrity, inspection readiness, and high-quality service delivery across Lonza's global network. The position provides strategic leadership to a team of system specialists and collaborates closely with Quality, Operations, and Business Process Owners to drive operational excellence, regulatory compliance, and continuous improvement.

What you will get:

* An agile career and dynamic working culture.

* An inclusive and ethical workplace.

* Compensation programs that recognize high performance.

* A variety of benefits dependent on role and location.

* The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

 What you will do:

 Leadership & Service Delivery Management

* Lead and develop a global Systems Office team supporting Document Management Systems (DMS), Cornerstone LMS, TrackWise, and gLIMS.

* Manage workload planning, resource allocation, and operational priorities across a global service delivery model.

* Build a high-performing team through effective hiring, onboarding, coaching, training, and performance management.

* Foster a culture of accountability, customer focus, compliance, and continuous improvement.

 Quality Systems Governance

* Establish and maintain governance frameworks, operating standards, and service delivery models for quality and learning systems.

* Ensure consistent and compliant administration of DMS, Cornerstone LMS, TrackWise, and gLIMS in alignment with business requirements and service level expectations.

* Partner with Business Process Owners to ensure systems effectively support business processes and quality objectives.

* Drive standardization of processes and practices across the organization.

Operational Excellence & Continuous Improvement

* Drive automation, simplification, harmonization, and continuous improvement initiatives across supported systems.

* Identify opportunities to improve efficiency, enhance user experience, and reduce operational risk.

* Lead the implementation of best practices and process optimization initiatives.

* Support system upgrades, enhancements, and transformation initiatives.

Compliance, Data Integrity & Inspection Readiness

* Ensure compliance with GMP, data integrity requirements, and applicable regulatory standards.

* Maintain inspection readiness through robust system controls, documentation, and operational governance.

* Oversee user access management, document lifecycle management, training administration, and quality system workflows.

* Ensure the integrity, accuracy, and reliability of system master data, reporting, and analytics.

Performance Management & Stakeholder Engagement

* Monitor and improve key performance indicators (KPIs), service level agreements (SLAs), compliance metrics, and operational performance measures.

* Act as the primary escalation point for critical system, compliance, and operational issues, ensuring timely resolution and mitigation of risks.

* Collaborate with Quality, Operations, IT, Learning, Regulatory, and Business stakeholders to drive effective system performance and continuous improvement.

* Communicate system performance, risks, and improvement opportunities to senior leadership.

Strategic Quality Systems Support

* Provide strategic direction for Quality Systems administration and governance across the global organization.

* Support regulatory inspections, audits, and compliance assessments.

* Contribute to the development and execution of Digital Quality and Quality Systems strategies.

* Perform other duties as assigned.

What we are looking for:

 Education

* Bachelor's degree or higher in Chemistry, Biochemistry, Pharmacy, Life Sciences, or a related scientific discipline.

* Advanced degree is preferred.

 Experience

* 10+ years of experience managing Quality Systems within a GMP-regulated environment.

* 10+ years of experience within the biopharmaceutical, pharmaceutical, biotechnology, or other highly regulated industry.

* Proven experience leading global teams and service delivery organizations.

* Experience with Document Management Systems (DMS), Learning Management Systems (LMS), TrackWise, gLIMS, or similar quality applications.

* Experience supporting inspections, audits, compliance programs, and data integrity initiatives.

* Experience driving operational excellence, process improvement, and digital transformation initiatives.

Skills

* Strong knowledge of GMP regulations, Quality Systems, and compliance requirements.

* Experience with DMS, Cornerstone LMS, TrackWise, gLIMS, and related quality technologies.

* Strong leadership, coaching, and stakeholder management skills.

* Excellent analytical, problem-solving, and decision-making abilities.

* Demonstrated ability to manage global operations and complex cross-functional initiatives.

* Strong communication and change management capabilities.

* Ability to drive standardization, automation, and continuous improvement.

Preferred Certifications

* GMP, Quality Systems, or Regulatory Compliance certifications.

* Project Management Professional (PMP) certification preferred.

Behaviors

* Demonstrates strong ownership and accountability.

* Leads through collaboration and influence.

* Champions quality, compliance, and data integrity.

* Develops high-performing teams and future talent.

* Drives innovation, operational excellence, and continuous improvement.

* Builds strong partnerships across functions and geographies.

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.