Seeking a clinical quality manager to lead activities across clinical development programs, ensuring compliance with Good Clinical Practice, FDA, MDR, and ISO requirements while supporting patient safety, data integrity, and inspection readiness.
The Clinical Quality Manager will oversee clinical quality systems, audits, CAPA investigations, CRO and site oversight, vendor qualification, and regulatory inspection preparation. This individual will partner closely with Clinical Operations and cross functional teams to identify quality risks, drive continuous improvement initiatives, manage clinical quality events, and ensure quality is embedded throughout all phases of clinical research and trial execution.
Key Requirements:
Bachelor's degree in a life science or related field, with at least five years of Clinical Quality Assurance experience, strong Google Cloud Platform expertise, experience supporting clinical investigations, CAPA ownership, CRO/vendor oversight, audit management, and regulatory inspections. Experience with implantable medical devices and electronic quality management systems (eQMS) is highly preferred.
The successful candidate will demonstrate strong leadership, sound quality judgment, problem solving skills, and the ability to thrive in a fast paced environment.
Qualifications:
- Strong medical device clinical quality and Google Cloud Platform experience
- Experience investigating and resolving complex clinical compliance issues through CAPAs
- CRO and clinical site oversight experience with clear understanding of sponsor responsibilities
- FDA inspection readiness experience and ability to prepare clinical teams for inspections
- Ability to act as a strategic quality partner while making risk based decisions to protect patient safety and compliance
Please note that sponsorship cannot be provided for this role
