Proclinical is seeking an experienced individual in Global Quality Auditing for a Lead position. This role will be responsible for creating quality strategies and ensure compliance with Risk Evaluation and Mitigation Strategies. The successful candidate will lead a dedicated department, manage multiple vendors and support Health Authority Inspections. This position requires a strategic thinker who can foster strong partnerships with internal stakeholders and drive quality improvements based on audit insights.

Responsibilities:

Oversee multiple auditing vendors and manage their performance and compliance.Conduct regular GVP & REMS audits.Manage audit findings, responses, and Corrective and Preventive Actions (CAPAs).Ensure accurate and timely data entry and issue Key Performance Indicators (KPIs) for trend analysis.Identify and escalate GVP & REMS compliance and data integrity concerns.Provide GVP compliance consulting and education to ensure regulatory and industry trends are met.Collaborate with key stakeholders to drive improvements and risk mitigation.Contribute to quality projects and initiatives.Represent the organization at industry associations and participate in expert working groups.Recruit and manage the team to align with strategic goals.Manage the department's budget and foster a culture of continuous improvement.

Key Skills and Requirements:

Education in a relevant scientific discipline.Experience in the pharmaceutical industry within regulated areas and/or Quality Assurance expertise.In-depth knowledge of the BioPharma business, including drug development and post-marketing obligations.Previous experience as an Auditor.Familiarity with Audit Management Tools, Controlled Document Management Systems, and Regulated Databases.Excellent communication and influencing skills.Ability to inspire confidence and trust at all levels.Skilled negotiator with the ability to influence and obtain cooperation from stakeholders.Commitment to patient welfare, quality, integrity, and reliability.Ability to manage workload, set priorities, and accept responsibility.Ability to evaluate quality management systems and operations independently.Excellent judgment and problem-solving skills.Willingness to travel nationally and internationally as needed (30% of the time).

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@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.