Good Clinical Practice (GCP) Auditors in Poland

Advarra; Polska; Hybrid; PLN 150,000 - 210,000; Full time

Job summary

Advarra is seeking Good Clinical Practice (GCP) Auditors to join our consultant network for Poland-based projects. Auditors support compliance reviews across GCP clinical sites and vendors.

You will conduct audits, evaluate sites and CROs, and prepare detailed reports with findings and corrective actions as needed. Based in Poland, you will collaborate with clients and QA leadership to ensure adherence to regulatory requirements.

Qualifications

• 10+ years of Clinical Quality Assurance experience.
• 5+ years of Good Clinical Practice auditing experience.
• Experience with regulatory expectations (FDA, EMA) and audit readiness.
• Experience developing QA plans, audit programs, and CAPA.
• Polish language at B2 level; English language at B2 level.

Responsibilities

• Conduct GCP audits (planning, agenda, on-site or remote, report writing).
• Evaluate investigator sites, CROs, and vendors for compliance.
• Prepare comprehensive audit reports detailing findings and root causes.

Skills

GCP auditing

Quality Assurance

Audit reporting

Regulatory familiarity

Stakeholder communication

Job description

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Good Clinical Practice (GCP) Auditors in Poland

Location

This role is open to candidates based in Poland.

Company Information

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.

Company Culture

Our people--both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

Job Overview Summary

Advarra is seeking Good Clinical Practice (GCP) Auditors to join our consultant network for Poland-based projects. Auditors support compliance reviews across GCP clinical sites and vendors.

Job Duties & Responsibilities

• Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing)
• Evaluate investigator sites, CROs, and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root-causes.
• If required will provide corrective actions support and present findings to QA leadership and stakeholders
• Work collaboratively with clients to ensure quality standards.

Basic Qualifications

• Minimum 10+ years of Clinical Quality Assurance and/or Good Clinical Practice (GCP) experience.
• Minimum 5+ years of Good Clinical Practices auditing experience.
• Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
• Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
• B2 level in Polish communication, verbal and written
• B2 level in English communication, verbal and written

Preferred Qualifications

• Strong interpersonal and client interaction skills.
• Excellent analytical, problem-solving, communication, and report-writing skills.
• Ability to work collaboratively across departments and interact with internal and external stakeholders.