Clinical Quality Manager - Fully Remote Direct Hire
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.
Help Shape the Future of Implantable Medical Devices
We're seeking an experienced Clinical Quality Manager to lead quality assurance activities supporting global clinical development programs. This is a highly visible role responsible for ensuring compliance with GCP, FDA, MDR, ISO requirements, and maintaining the highest standards of patient safety and data integrity.
Key Responsibilities
Integrate Clinical Quality processes into the Quality Management System (QMS)
Lead risk-based clinical quality initiatives
Oversee:
- GCP compliance
- Clinical quality audits
- Vendor qualification and oversight
- CRO performance management
- Quality agreements
- Regulatory inspection readiness
Conduct audits of:
- Clinical sites
- CROs and vendors
- Trial Master Files (TMF)
- Clinical databases
- Pharmacovigilance systems
Lead CAPAs, quality investigations, and continuous improvement initiatives
Serve as the Clinical Quality representative across cross-functional clinical teams
Develop and deliver GCP training programs
Qualifications
- Bachelor's degree in Life Sciences, Biotechnology, or related field
- Advanced degree preferred
- 5+ years of Clinical Quality Assurance experience
- Strong GCP background
- Experience supporting regulatory inspections
- Experience with electronic Quality Management Systems (eQMS)
Highly Preferred Experience
Implantable Medical Devices - Neuromodulation products would be a huge bonus
FDA, MDR, and ISO compliance
Clinical trial quality oversight
Clinical vendor and CRO management
Risk-based quality management programs
Inspection readiness and regulatory audits
Clinical Quality Manager (Class 3 Med Device) in united at Unknown Company
This position is listed as full time and able to be worked remotely.