Senior Specialist, Regulatory Programs (Part-Time)

GeneFab

Alameda, CA Onsite Quality Assurance Part-Time / Fractional

About this role

We are seeking an experienced and dynamic Quality Regulatory Program Manager to lead our quality assurance regulatory initiatives. As the Program Manager, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards in manufacturing processes, and driving continuous improvement initiatives to enhance product quality and patient safety. This key role will develop and implement regulatory strategies leading to successful registration and life-cycle management of complex products serving patients and clients. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.