Senior Auditor, Clinical Quality and Compliance - Remote

Overview

The role of the Sr. Auditor, Clinical Quality and Compliance is to act as lead person in the establishing audit plans, assessing/securing compliance in study conduct and to provide strong support to operations via GxP consultation.

In Short

• Implement robust audits plan and execute audits in accordance with the established audit program.
• Act as a lead/mentor for the conduct of audit activities (site, studies, internal and vendors).
• Coordinate and conduct clinical sites audit with the project management team.
• Participate in the auditor’s training in providing guidance on audit techniques.
• Formulate observation/recommendations and review appropriateness of audit responses.
• Review and assess non-compliances and track the progress of action items.
• Provide solid recommendation/guidance via GxP consultation.
• Organize and host sponsor’s study audits and regulatory inspections.
• Work closely with the Quality Systems group for internal audits.
• Develop training content for topics related to SOP, regulations and GxP.

Requirements

• Bachelor degree in a relevant discipline or equivalent experience.
• 5-10 years’ experience in the pharmaceutical or research industry.
• Excellent knowledge of ICH guidelines, FDA and local regulatory requirements.
• Master the overall audit process and risk determination.
• Ability to communicate effectively both orally and in writing.
• Good organization skill and ability to adapt to a rapidly growing environment.
• Fluency in Polish and English is required.
• Good knowledge of the Microsoft Office Suite.
• Willing to travel 10-30% of the time.

Benefits

• Permanent full-time position.
• Flexible schedule.
• Vacation.
• Home-based position.
• Ongoing learning and development.