• Provide Quality System Management consulting services to pharmaceutical, biotechnology, biorepository, and other healthcare industries per cGMP, GLP, GCP standards along with other relevant industry best practices.• Implement new innovative Quality Management Solutions surrounding GMP manufacturing, including electronic Quality Management Systems (document control, training, CAPA, change control), validation master plans of equipment and software, and compliance with data integrity.• Perform audits of third-party suppliers and laboratories to ensure compliance with industry regulations and establish Quality Agreements with clients.• Evaluate existing and proposed IT infrastructure and enterprise software solutions for compliance with 21CFR part 11/GAMP 5 and propose implementation and validation plans to ensure data integrity.• Establish new business continuity plans and disaster recovery procedures by evaluation of existing critical business systems, creating inventory and contact lists, and proposing new backup equipment where applicable.• Provide equipment and environmental validation services including temperature mapping multiple types of storage environments including reach-in refrigerated storage, liquid nitrogen tanks, and large warehouses containing multiple walk-in storage spaces.