Temporary Manager, Gcp Auditing

Overview

• Lead risk-based quality auditing activities in compliance with GCP and international regulations.
• Utilize expertise in FDA and EU regulations and ICH guidance documents for auditing processes.
• Conduct various audit types including process, site, vendor, and license partner audits.
• Collaborate with cross-functional teams on compliance projects and initiatives.
• Develop and implement risk-based audit programs for clinical studies.
• Participate in regulatory inspections and support inspection room activities.
• Provide training, orientation, and mentoring to new GDQA staff.
• Work remotely and manage responsibilities independently with occasional travel.

Key Responsibilities & Duties

• Manage the full audit lifecycle, including scheduling, preparation, execution, reporting, and follow-up.
• Conduct internal and external audits globally to ensure compliance with GCP standards.
• Represent GDQA in compliance projects and cross-functional team initiatives.
• Develop risk-based audit strategies for assigned clinical studies.
• Interpret regulations and policies to address critical compliance issues.
• Support regulatory inspections as part of the control and inspection room team.
• Mentor and train new GDQA staff to enhance team capabilities.
• Ensure effective collaboration with senior leaders and external stakeholders.

Job Requirements

• Bachelor's degree in science or a related field is required.
• Minimum of 6 years of relevant industry experience with 4 years in GCP auditing.
• Proficiency in FDA and EU regulations and ICH guidance documents.
• Strong leadership and collaboration skills with senior leaders.
• Excellent communication skills for effective interaction at all organizational levels.
• Ability to work independently and take initiative in complex situations.
• Willingness to travel 30-40% domestically and internationally.
• Experience in training and mentoring staff in quality auditing practices.