Marla Shelton

Director of Validation at AES

Specializing in aligning vendors, technology teams, and business operations with regulatory and industry standards, Marla is an expert in creating and managing Quality Assurance frameworks. 

In her current role at AES, Marla oversees the equipment qualification and process validation strategy across all operations to ensure compliance with company standards and regulatory requirements.  She provides strategic and technical support to operations, network functions, and project teams to ensure the implementation of the validation life cycle for products, equipment, facilities and utilities to deliver robust and contemporary manufacturing processes end to end.  

Before joining AES, Marla held significant roles at Atara Bio and Celerion.  At Atara, she was pivotal in overseeing the company’s Computer System Validation/E-Compliance programs to ensure the compliance of cGMP systems. She developed and implemented validation strategies, policies, SOPs, protocols, and other documentation for systems such as ERP, LIMS, and Quality Management Systems. Marla’s contributions were crucial to the successful market launch of the company’s first drug therapy in the EU, and she played a key role in inspection readiness teams to identify and mitigate gaps. 

 At Celerion, Marla led software and laboratory equipment validation and qualification activities, managed a team responsible for system audit programs for Computer Systems Validation and IT, conducting risk assessments and ensuring compliance with regulatory requirements.