Note: The job is a remote job and is open to candidates in USA. The Davis Companies is seeking an experienced Clinical Quality Manager to support global clinical development programs for implantable medical devices. The role leads clinical quality assurance activities, ensuring compliance with GCP, FDA, MDR, and ISO requirements while maintaining patient safety and data integrity.
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
Skills
- Bachelor's degree in Life Sciences, Biotechnology, or related field
- 5+ years of Clinical Quality Assurance experience
- Strong GCP background
- Experience supporting regulatory inspections
- Experience with electronic Quality Management Systems (eQMS)
- Advanced degree preferred
- 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
Benefits
- Fully remote
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