Associate Director, Global Quality Lead Auditing Technology

Proclinical is seeking an Associate Director, Global Quality Lead Auditing Technology. This role will maintain and put into place a Quality Auditing Strategy, making sure all complies with regulatory requirements and the Global Quality Management System. The successful candidate will ensure technology solutions supporting R&D and PV meet compliance standards and mitigate related risks. This role also involves providing expert input on processes impacted by technology and staying informed of industry trends.

Responsibilities:

• Develop and maintain the Global Audit Programs using a risk-based approach.
• Ensure timely follow-up and CAPA closure for audits.
• Prepare sites for regulatory inspections, providing on-site or remote support as needed.
• Input audit data into the Audit Management Tool accurately and timely.
• Provide data and feedback to internal stakeholders regarding quality compliance status.
• Identify and mitigate compliance risks, resolving potential regulatory observations.
• Escalate critical compliance risks/issues to leadership.
• Provide technical and compliance guidance as a committee member.
• Lead improvement initiatives to enhance Corporate QA processes.
• Stay updated on regulatory and industry trends and share key information within the network.

Key Skills and Requirements:

• Education in a scientific discipline like Computer Science, Bioinformatics, Engineering etc.
• Experience in a quality role, preferably as an auditor.
• Experience in software development, including security, data privacy, and software verification.
• Experience with In Vitro Diagnostic Medical Devices.
• Strong presentation, training, interpersonal, negotiation, and organizational skills.
• Ability to build partnerships and prioritize based on compliance and patient safety risks.
• Skilled in audit management tools, document systems, and regulated databases.
• Capable of national and international travel (30% of the time).
• Knowledge of statistical principles, programming, and cloud collaboration tools.
• Understanding of ICH-GCP, domestic/international regulations, and quality principles.
• Fluent in English; additional languages are a plus.

If you are having difficulty in applying or if you have any questions, please contact George Kyriacou at g.kyriacou@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.