Vice President – Quality Assurance

This is a fully remote position, open to applicants in Europe.

📋 Description

• Lead and provide strategic direction to a developing quality and regulatory department.

• Oversee the development of organizational capabilities within the quality system, including succession planning and performance standards.

• Establish recommendations for process and system strategies, compliance-driven standards, and harmonization boundaries.

• Formulate and execute the strategy for maintaining Clinilabs Quality Systems.

• Act as a subject matter expert and resource leader in quality systems.

• Direct the validation of computer systems and software, especially those regulated under GCP.

• Perform internal and external audits to ensure compliance with company SOPs.

• Offer feedback to the quality control team.

• Create and uphold processes, standards, and procedures that align with regulatory requirements.

• Engage with the FDA and other regulatory agencies.

• Carry out qualification audits of contractors and suppliers.

• Provide leadership and direction on quality agreements.

• Develop metrics to assess the effectiveness of the quality system.

• Identify quality-related issues and areas for improvement.

• Supervise employee training and the training program.

• Manage the controlled document management system.

• Conduct or oversee both internal and external audits.

• Develop or oversee the vendor qualification program.

• Perform additional duties as assigned.

⛳️ Requirements

• A minimum of a Bachelor’s degree is required; advanced degrees are preferred.

• At least 15 years of experience in a GXP function.

• A minimum of 10 years of leadership experience in quality and/or compliance.

• Demonstrated experience in leading FDA, MHRA, and other regulatory inspection readiness, activities, and responses.

• Strong skills in influencing, negotiation, and leadership without direct authority.

• Ability to navigate complexity and manage a diverse team.

• Exceptional written and verbal communication and interpersonal skills.

• Proven leadership, influencing, and collaboration abilities.

• Experience in a regulated industry is required.

• Capability to work and communicate effectively in a cross-cultural setting.

• Prior experience in driving performance results.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional growth and development.

• Collaborative and supportive work environment.