Temporary Manager, Gcp Auditing

Overview

• Lead and manage global GCP auditing activities, ensuring compliance with regulatory standards and guidelines across clinical studies.
• Collaborate with cross-functional teams to enhance quality and compliance strategies, driving impactful improvements.
• Conduct risk-based audits, including site, vendor, and process evaluations, identifying and mitigating compliance risks effectively.
• Provide expertise in FDA, EU regulations, and ICH guidelines to support regulatory inspections and initiatives.
• Develop and implement tailored audit programs aligned with clinical study requirements and organizational objectives.
• Support inspection readiness activities, contributing to successful regulatory reviews and organizational compliance.
• Mentor and train auditing staff, fostering team capabilities and ensuring high-quality outcomes.
• Work remotely with occasional travel, maintaining autonomy while delivering impactful results globally.

Key Responsibilities & Duties

• Plan, execute, and report on audits across various domains to ensure compliance with GCP standards.
• Develop and implement risk-based audit strategies tailored to clinical study requirements.
• Collaborate with senior leaders and stakeholders to address compliance issues and improve processes effectively.
• Interpret and apply regulatory guidelines to resolve critical compliance challenges and ensure adherence.
• Support regulatory inspections by managing inspection room activities and documentation requirements.
• Provide training and mentorship to auditing staff, enhancing team expertise and professional growth.
• Ensure effective communication and collaboration across teams to achieve organizational compliance goals.
• Travel as required to conduct audits and support compliance initiatives globally.

Job Requirements

• Bachelor's degree in science or a related field is required.
• Minimum of 6 years of industry experience, with at least 4 years in GCP auditing roles.
• Proficiency in FDA, EU regulations, and ICH guidelines is essential for success.
• Strong leadership and collaboration skills to engage effectively with stakeholders and teams.
• Excellent communication skills to interact across organizational levels and functions.
• Ability to work independently, managing complex tasks with minimal supervision.
• Willingness to travel 30-40% domestically and internationally as needed.
• Experience in training and mentoring staff to foster professional growth and team development.