Remote Clinical Quality Manager – Implantable Medical Devices

The Davis Companies; United States; À distance; USD 120 000 - 160 000; Plein temps

Avantages offerts par ce poste

Fully remote

Résumé du poste

The Davis Companies seeks a Remote Clinical Quality Manager to lead QA activities for global clinical development programs. You will ensure GCP, FDA, MDR, and ISO compliance, drive risk-based QA initiatives, and maintain patient safety and data integrity across studies.

The role requires directing audits, CAPAs, and training across cross-functional teams, with a focus on continuous improvement in a fully remote, direct-hire capacity.

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).

Responsabilités

• Integrate Clinical Quality processes into the Quality Management System (QMS).
• Lead risk-based clinical quality initiatives.
• 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.
• Conduct audits of clinical databases and 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.

Connaissances

Clinical QA

GCP

Regulatory inspections

eQMS

Advanced degree

Bachelor's degree

Formation

Bachelor's degree in Life Sciences

Advanced degree

Description du poste

The Davis Companies seeks a Remote Clinical Quality Manager to lead QA activities for global clinical development programs. You will ensure GCP, FDA, MDR, and ISO compliance, drive risk-based QA initiatives, and maintain patient safety and data integrity across studies.

The role requires directing audits, CAPAs, and training across cross-functional teams, with a focus on continuous improvement in a fully remote, direct-hire capacity.