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̽»¨ºÏ¼¯ 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.

̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.