Clinical FSP Quality Manager

IQVIA AG seeks a Senior Clinical FSP Quality Manager in Switzerland to oversee GCP compliance, manage risk, and support quality initiatives for clinical delivery units.

This individual contributor role is embedded within specific Delivery Units or business lines. The primary objective is to collaborate with global and regional Quality Management teams to implement the global Quality Plan. The position serves as a local expert in Good Clinical Practice (GCP), providing guidance on quality control, risk mitigation, and corrective actions to clinical staff and key stakeholders.

Responsibilities

• Oversee compliance at the country and site levels using a risk-based methodology.
• Detect compliance risks, perform site assessments, and oversee the management of Corrective and Preventive Actions (CAPAs).
• Act as the local GCP subject matter expert during inspections and audits.
• Ensure inspection readiness and maintain high compliance standards at the country level.
• Implement the global Quality Management Plan within the assigned scope.
• Identify and assess risks by reviewing data and executing quality control processes.
• Assist in risk mitigation strategies, planning corrective actions, and providing guidance for process improvements.
• Collaborate with business line management and staff to boost operational effectiveness.
• Partner with relevant stakeholders to keep quality as a central focus in project delivery.
• Develop and monitor the implementation of Delivery Unit or Sponsor-specific Quality Management and Risk Management plans.
• Advise teams and stakeholders on all aspects of GCP compliance.
• Work with teams to address non-compliance and quality issues, supporting the planning of CAPAs according to Standard Operating Procedures (SOPs).

Requirements

• Minimum of nine years of professional experience.
• Background in Clinical Operations combined with experience in GCP and compliance.
• Proven expertise in site oversight and risk management.
• Bachelor's Degree or an equivalent qualification.
• Solid understanding of medical terminology, SOPs, ICH guidelines, GCP, and relevant regulatory requirements.
• Familiarity with quality management processes, national and international regulations, and drug development workflows.
• Knowledge of Clinical Research Organization (CRO) or pharmaceutical industry operations.
• Awareness of IQVIA corporate standards and SOPs.
• Strong organizational, interpersonal, and communication abilities.
• Sound judgment and decision-making capabilities.
• Effective influencing and negotiation skills.
• Proficiency in Microsoft Office applications.
• Excellent problem-solving aptitude.
• Willingness and ability to travel within the region or country.
• Capacity to lead and motivate clinical teams.
• Skill in building and maintaining productive relationships with colleagues, managers, and clients.
• Fluent proficiency in English.

Nice to have

• Experience in oncology is preferred.