Pharmaceutical Quality GCP EMA Mock Inspector (Consulting)

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Location

This role is open to candidates based through the European Union.

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) Mock Inspectors with previous EU Health Authority work experience to join our consultant network for EU-based projects. Mock Inspectors support compliance reviews across GCP Sponsors, sites and vendors.

Job Duties & Responsibilities

• Conduct Good Clinical Practice (GCP) mock inspections (planning, agenda, physical investigation, coaching, and report writing)
• Evaluate Sponsors, CROs, and investigator sites, .
• Prepare comprehensive inspection reports detailing findings.
• Provide written inspection reports in English.
• Work collaboratively with clients to ensure quality standards.

Basic Qualifications

• Minimum 10+ years of Quality Assurance and/or Good Clinical Practice (GCP) experience.
• Minimum 5+ years of Good Clinical Practice (GCP) inspection experience.
• Demonstrated work history at any European Health Authority.
• Demonstrated experience in leading, developing and conducting investigation activities.
• B2 level in English communication, verbal and written
• Bachelor's degree

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.