Job Title: AI/ML & Digital Quality & Compliance Lead
Description:
We are seeking an experienced AI/ML & Digital Quality Lead to provide Quality Assurance guidance while designing and implementing cutting-edge AI/ML/Digital solutions in a GMP Environment.
You will work with the business, data scientists, and IT to design and implement an Artificial Intelligence and Machine Learning (AI/ML) Systems Governance Framework to support GMP business objectives.
Your key responsibilities include:
* Designing and implementing AI/ML systems that meet regulatory requirements
* Developing and maintaining documentation for AI/ML systems
* Ensuring compliance with relevant regulations and industry standards
* Collaborating with cross-functional teams to identify business needs and propose technical solutions
* Staying up-to-date with emerging AI/ML technologies and assessing their impact on the organization's technical landscape
Requirements:
* BS/MS degree or equivalent in Science or Engineering Field
* 4+ years of relevant work experience OR an equivalent mix of education and work experience
* Experience in designing and/or implementing AI/ML/Advanced Digital Analytic systems in a commercial environment
* Strong knowledge of AI/ML technologies, including deep learning, natural language processing, and computer vision
* Knowledge of Pharmaceutical Regulations (FDA/EMA) and how they relate to computerized systems
* Programming languages such as Python, R, Julia, etc.
* Data processing and storage technologies such as Hadoop, Spark, and NoSQL databases
* Cloud computing platforms such as AWS, Azure, or Google Cloud Platform
* ML Ops experience: model tracking and governance, multiple models in different production contexts, etc.
* Excellent problem-solving and analytical skills
* Excellent communication and collaboration skills
* Strong leadership skills
* Diverse technical experience
* Data modeling and data exploration tools
Company Culture:
We strive to deliver 3-5x more benefits to our patients at half the cost to society as part of our 2030 Pharma vision.
In CSQA, we partner across major global business functions – PTQ, PT Digital & Operational Excellence (PTE), PT-Development, PT-Regulatory, and PT-Manufacturing, and our partners in Global Informatics.