QMS Implementation & Quality Lead - Clinical Trials

Rephine; Barcelona; Vor Ort; EUR 81.000 - 116.000; Vollzeit

Zusammenfassung

Rephine is seeking a CQM Lead to drive risk-based quality initiatives across assigned units. You will develop and implement Quality Management Plans, identify risks, and support CAPAs while ensuring GCP compliance and regulatory alignment.

You will lead QA activities, collaborate with cross-functional teams, and support audits and inspections across regions. Fluency in English and willingness to travel are essential.

Qualifikationen

• Bachelor's or Master's in Medical or Life Science; PhD preferred.
• 12+ years in clinical trial design, planning, startup, conduct, analysis, and reporting.
• Strong knowledge of ICH, GCP, SOPs and regulatory requirements.
• Excellent organizational, interpersonal, and communication skills.
• Ability to travel within the region/country.
• Fluent in English.

Aufgaben

• Lead risk-based quality improvements across designated units and studies.
• Develop and implement Quality Management Plans and risk-based processes.
• Provide guidance on GCP compliance and regulatory requirements to teams.
• Support audits and regulatory inspections as required by SOPs.
• Coordinate corrective/preventive actions and monitor implementation.
• Lead and develop QA staff, manage performance and resources.

Kenntnisse

Risk-based quality

Study management

Quality Management Plan

Risk assessment

Corrective/Preventive Actions

GCP compliance

Audits

Regulatory inspections

Leadership

People management

Microsoft Office

Ausbildung

Bachelor's or Master's in Medical or Life Science

PhD preferred

Tools

Microsoft Office

Jobbeschreibung

Rephine is seeking a CQM Lead to drive risk-based quality initiatives across assigned units. You will develop and implement Quality Management Plans, identify risks, and support CAPAs while ensuring GCP compliance and regulatory alignment.

You will lead QA activities, collaborate with cross-functional teams, and support audits and inspections across regions. Fluency in English and willingness to travel are essential.