Digital Quality, IT Project Quality Manager - LIMS
Lonza
This listing was originally posted on Lonza's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Location: Hyderabad
Be part of Lonza’s world-class Quality and Regulatory team. As an IT Project Quality Manager specializing in Laboratory Information Management Systems (LIMS), you will be a key contributor to our Global Capability Center (GCC). You will be responsible for the qualification and validation compliance of computerized systems used for cGMP activities, driving the planning and timely execution of validation deliverables to ensure the highest standards of data integrity and regulatory compliance.
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 regulatory and IT workstreams.
Comprehensive benefits package including medical insurance and wellness programs.
Validation Planning: Create and maintain a comprehensive validation execution plan in alignment with project timelines, budgets, and Lonza’s Quality Management System (QMS).
LIMS & CSV Oversight: Lead the planning and timely execution of validation deliverables for LIMS and other computerized systems, ensuring all cGMP activities meet global compliance standards.
Test Management: Take responsibility for the timely and compliant setup and execution of tests within Lonza’s Test Management System (Kneat), monitoring progress from script creation through to final review.
Project QA Leadership: Act as the voice of Quality in cross-functional teams, driving CSV strategy and standards across the Lonza global network during all project phases.
Documentation & Approval: Review and approve technical documentation, risk assessments, CSV protocols, reports, test scripts, and deviations to ensure adherence to Lonza quality standards.
Training & Advisory: Ensure project team members are trained according to Lonza IT requirements and advise teams on processes, standards, and procedures.
Regulatory Compliance: Ensure alignment with cGMP and regulatory requirements (e.g., FDA, Swissmedic) by providing CSV guidance and translating regulatory trends into actionable quality improvement projects.
Stakeholder Collaboration: Work closely with Global Quality, IT PMO, and IT Centers of Excellence (CoE) to ensure harmonization of qualification and validation standards.
Audit Support: Support internal audits and regulatory inspections by providing summarized validation data and overseeing the preparation of regulatory responses.
Data Integrity: Uphold and improve data integrity processes in accordance with Lonza policies, proactively identifying and escalating potential risks.
Experience: Significant experience in the Pharmaceutical industry with a focus on Computer Systems Validation (CSV); deep experience with LIMS or MES implementation is highly preferred.
Education: Degree in Life Sciences, Computer Science, Engineering, or a related field.
Technical Knowledge: Strong understanding of GxP, GAMP 5, and 21 CFR Part 11; familiarity with Laboratory Information Management Systems (LIMS) and test management tools like Kneat.
Project Management: Proven ability to manage CSV deliverables within complex IT project timelines and budgets.
Soft Skills: Detail-oriented, organized self-starter with excellent problem-solving skills and the ability to interface with diverse global stakeholders.
Communication: Business fluency in English with the ability to lead quality discussions in a cross-functional, global environment.
Mindset: A collaborative team player who takes personal accountability for quality outcomes and is committed to continuous process improvement.
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.
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