Associate Director/Sr. Manager, Quality Systems

Associate Director/Sr. Manager, Quality Systems

Location: Redwood City, CA

Company Description

Position Description 


The Associate Director/Sr. Manager, Quality Systems is responsible for implementing, maintaining and monitoring Rezolute’s Quality Management System processes to ensure regulatory compliance and service quality and is responsible for driving continuous improvement in the effectiveness, efficiency, and scalability of the quality management system.

This individual is a critical change agent for the organization making use of process excellence methodologies and current best practices in these continuous improvement efforts. Success in this position requires close collaboration and effective communication with key process owners, such as Clinical Operations, Technical Operations, and other functional areas, creating and continuously improving scalable and effective systems for ensuring consistent product quality and regulatory compliance.

The successful candidate will have the expertise, creativity, and communication skills to provide leadership in the design and ongoing application of these quality systems within the evolving regulatory landscape for pharmaceutical  and clinical laboratory services in the US, Europe, and elsewhere and ensuring the overall test system (people, process, equipment, reagents, and software) is consistently functioning as intended and is compliant with applicable regulations, standards and quality management system requirements.

Responsibilities Include

Candidate Profile

Qualifications/Requirements - We are looking for a candidate with:

Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that is:

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