Collaborate and establish procedures with technical operations and manufacturing staff to ensure that clinical supply and commercial manufacturing activities are conducted in compliance with applicable GMP requirements.
The Director of Quality Systems develops, establishes, implements and maintains effective quality systems through policies, processes, procedures and controls that ensure process and product quality and compliance with global regulatory agencies.
In this role, you will oversee the development, implementation and monitoring of Molina national and state-based Quality Interventions to ensure they meet state and federal intervention rules and are aligned with best practices as identified in the healthcare quality improvement literature and within Molina plans.
In this role, the selected candidate will provide guidance and technical expertise to QC Chemistry personnel in all areas of Quality Control functions, including finished product, raw material and stability.
Responsible for total compliance with all applicable corporate policies and procedures, corporate and divisional specifications, local standard operating procedures, 510K requirements, and all other applicable regulatory requirements.
In this role, you will be responsible for the development and implementation of policies and procedures for Laboratory Controls system to ensure compliance with regulatory requirements and industry standards.