Senior Compliance Specialist (Documentation & Reporting)

Location: Hyderabad

Be part of Lonza’s world-class Quality Systems & Compliance team. As a Compliance Specialist (Documentation & Reporting), you will be responsible for coordinating key Quality System processes and ensuring the timely, compliant, and effective execution of site-wide quality governance activities. You will play a vital role in maintaining our high standards by overseeing final SOP approvals, managing Quality Council preparation, and providing operational support for customer complaints and GAP assessments.

What you will get

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• Exposure to site-wide quality governance and global compliance standards.

• The opportunity to work at a leading-edge biologics manufacturing site.

• The full list of our global benefits can also be found on https://www.lonza.com/careers/benefits.

What you will do

• Perform final QA approvals for local Standard Operating Procedures (SOPs) prior to release, ensuring strict adherence to documentation standards and governance requirements.

• Coordinate Quality Council activities by compiling monthly performance data, updating relevant datasets, and managing critical communication to stakeholders.

• Manage GAP Assessment workflows by opening and assigning TrackWise records and ensuring structured, timely follow-up on all identified actions.

• Oversee Customer Complaint coordination, initiating TrackWise records and ensuring proper tracking and follow-up through to final closure.

• Provide general QMS support on an as-needed basis to ensure the continuous improvement and operational readiness of the Quality Management System.

• Collaborate with cross-functional teams to ensure that all quality governance activities are aligned with Lonza’s global compliance expectations.

What we are looking for

• Degree in Life Sciences, Pharmacy, or a related technical discipline; or equivalent experience in a regulated industry.

• Proven experience in Quality Assurance or Compliance, with a strong focus on documentation management and GxP standards.

• Proficiency in TrackWise and other Quality Management Systems (QMS) is highly advantageous.

• Analytical mindset with the ability to compile, interpret, and report on quality performance data.

• Strong attention to detail and a high degree of accuracy in reviewing and approving technical documentation.

• Excellent organizational and communication skills, with the ability to manage multiple timelines and interact effectively with various stakeholders.

• Fluent in English and German (written and spoken) to support the local site and global reporting requirements.

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.