We are currently seeking an experienced leader to manage and execute total quality management systems for our External Supply organization.
Responsibilities include:
* Executing nonconformance, CAPA, SICAR, Change Control and metrics oversight responsibilities.
* Acting as the category owner for all quality records and procedures.
* Processing, investigating and acting as first responders to deviations.
* Addressing and expediting product deviation under our company's quality management system procedures, ensuring compliance with regulatory agencies.
* Monitoring, investigating deviations and determining corrective and preventive actions to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses.
* Maintaining unified product defect investigation operating procedures.
* Providing technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent reoccurring events.
* Maintaining and monitoring systems to ensure that all deviations received are appropriately investigated and concluded per our company's quality standards and procedures.
* Communicating with all levels of the organization, facilitating development of solutions to critical business issues, and effectively defining objectives to enable effective metric generation and reporting.
* Serving as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites.
Requirements include:
* 6+ years related work experience in Biotech or pharmaceutical industry with demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
* Understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
* Thorough working knowledge of EU and US cGMPs regulations
* Able to defend processes, procedures, and decisions during regulatory inspections.