“The idea is to get the information in real time. And for that, you would go and see what systems you have at hand, what system your CMO is using, and find a joint ‘Safe Space’, which serves both sides.” – Ingrid Lux
Ingrid Lux, Lead Quality Disposition in Oncology & Small Molecule External Supply Europe at Takeda, brings 16+ years of pharmaceutical quality expertise from her previous role at Sandoz.
In the latest PharmaSource podcast, she shares insights on managing quality across external manufacturing networks and creating effective CDMO partnerships.
The Evolution of Quality Oversight
Ingrid entered the pharmaceutical industry during a pivotal consolidation period when smaller, complete companies were being acquired by larger players. This shift created new challenges for quality professionals.
“You took responsibility for products which weren’t manufactured at the site you were directly overseeing,” she explains. “Quality systems evolved over the borders of the own organisation, which implied a lot of coordination and cooperation with different organisational cultures.”
Breaking Down Silos
Early in her career, Ingrid observed significant silo thinking where quality was perceived as a roadblock. She emphasizes the transformation that has occurred: “All functions in global pharmaceutical companies living in our silos do have our strength. But these tools cannot only stay there. They need to serve all the other departments.”
The unified goal is clear: “We want to have the same goal – a good, solid and robust product. To achieve that, we are fulfilling the needs of GMP, which means deviations are mentioned and change controls are monitored because that gives robustness.”
Creating ‘Safe Spaces’ with CDMOs
Ingrid’s innovative approach involves creating “safe spaces” for real-time information sharing with CDMOs while protecting sensitive data.
“The CDMO would enter the figures in real life, and they would be transposed in real life in the interface you can see and read,” she explains. “This interface needs to protect both sides from unauthorized information access.”
Navigating Digital Challenges
The industry has evolved beyond basic IT implementation. “We are no longer in the IT project phase. We are in the pure digitalization phase,” Ingrid notes. Key challenges include:
- System integration: Making different systems cooperate through interfaces
- Data ownership: Ensuring specialists maintain correct information status
- AI collaboration: Understanding where artificial intelligence helps and where it misleads
Just-in-Time Quality Management
Ingrid distinguishes between speed and precision: “Speed would mean rush, but a clear definition of time, clear agreements, and their authenticity ensures reliability which might be perceived as speed because it was finished right in time, just-in-time.”
She compares this to dancing: “Most of the time you are moving and maintaining rhythm, and at a certain moment, the music gets more intense and you are prepared to do the most impressive movements because you were prepared.”
Practical Strategies for External Quality Management
Build Cross-Cultural Bridges “With external partners, you need to get in contact with people to create the same understanding through communication, conversation, but also consolidated information in documents like quality agreements.”
Implement Joint Problem-Solving Ingrid’s key success strategy: “Solve seven big problems together, and then the silos are going to melt.” Collaborative problem-solving naturally breaks down departmental barriers.
Ensure Early Quality Involvement Quality teams must be involved from development’s earliest stages with structured questions and answers before progressing to next steps.
Establish Data Validation Protocols “If you are an expert in your domain, you can understand the consistency of data you are receiving. The human expertise is still essential to understand how AI is working.”
Develop Contingency Planning Address current global supply challenges: “What is currently challenging is how we move products best by flight or by sea. If you can rely on your quality releases, you would lower inventory, but you need sound control on the entire logistic lane.”
Maintaining Perspective
Ingrid’s final advice centers on balanced application of quality standards: “We have a lot of rules and systems which are important to be followed, but please do not get mad with them. Understand what’s behind it, because if you get stuck on a certain idea, it won’t promote compliance, product, or effectiveness.”
This approach transforms quality from roadblock to enabler, creating easier communication and more successful external partnerships while ensuring both compliance and operational excellence.
