VP, Quality & Regulatory Compliance - Strategic Leader

Clinilabs; Basel; Hybrid; CHF 250.000 - 380.000; Vollzeit

Zusammenfassung

Clinilabs seeks a Vice President of Quality Assurance to lead the quality and regulatory teams, shaping strategy for quality systems and compliant operations across clinical trials. You will ensure cGCP adherence, regulatory readiness, and harmonization of processes within the organization.

This role requires deep GXP experience, strong leadership, and the ability to mentor staff while engaging with FDA, MHRA, and other regulators to drive compliant outcomes.

Qualifikationen

• Bachelor’s degree required; advanced degrees preferred.
• Minimum 15 years in a GXP function.
• At least 10 years in a leadership role in quality/compliance.
• Proven experience with FDA/MHRA inspections and responses.
• Strong influencing and cross-functional leadership abilities.
• Experience leading regulatory inspections without direct line authority.
• Ability to manage complex, diverse teams in regulated industry.
• Excellent written and oral communication and collaboration skills.
• Cross-cultural communication experience required.
• Prior experience driving performance results.

Aufgaben

• Provide leadership to growing quality and regulatory department.
• Develop strategy and maintain Clinilabs Quality Systems.
• Interact with regulatory bodies such as FDA/MHRA.
• Oversee internal and external audits.
• Develop and monitor vendor qualification programs.
• Mentor staff to prepare for higher responsibilities.
• Lead process and system strategy decisions for harmonization.
• Ensure regulatory compliance of clinical activities.

Kenntnisse

Leadership

Regulatory expertise

Quality systems

GXP

Cross-functional leadership

Audits

Communication

Ausbildung

Bachelor’s degree

Advanced degree preferred

Jobbeschreibung

Clinilabs seeks a Vice President of Quality Assurance to lead the quality and regulatory teams, shaping strategy for quality systems and compliant operations across clinical trials. You will ensure cGCP adherence, regulatory readiness, and harmonization of processes within the organization.

This role requires deep GXP experience, strong leadership, and the ability to mentor staff while engaging with FDA, MHRA, and other regulators to drive compliant outcomes.