Remote Clinical Quality Manager – Implantable Medical Devices

The Davis Companies; United States; Remote; USD 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Fully remote

Zusammenfassung

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.

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

Clinical QA

GCP

Regulatory inspections

eQMS

Advanced degree

Bachelor's degree

Ausbildung

Bachelor's degree in Life Sciences

Advanced degree

Jobbeschreibung

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.