GCP Auditor (Freelance - West Coast USA)

Ergomed Group; Northern (KY); On-site; USD 110,000 - 160,000; Full time

Job summary

Ergomed Group seeks a GCP Auditor to plan, conduct and report on GCP audits within the pharmaceutical sector, ensuring adherence to regulatory standards and client expectations across diverse projects.

Role features up to 40% travel, capability to conduct remote audits, and collaboration with a global team to uphold quality, integrity and patient safety in every engagement.

Qualifications

• GCP auditing experience across sponsor and site activities.
• Experience leading internal and external audits in pharma/biotech.
• Knowledge of national and international GCP legislation and guidelines.

Responsibilities

• Plan, prepare, conduct, report and follow up on GCP audits.
• Execute audits with understanding of regulatory requirements and GCP.
• Perform GCP quality assurance projects for clients in pharma/biotech.
• Coordinate inspection preparation activities for GCP process inspections.
• Lead mock inspections to Competent Authority standards when applicable.

Skills

GCP Audits

Regulatory Knowledge

Audit Planning

Cross-functional Collaboration

Education

BSc in Life Science

Job description

GCP Auditor (Freelance - West Coast USA)

• Full-time
• Department: GCP Compliance

Medicine moves forward here. So will you.

ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences.

We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring.

Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field.

Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines

Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP).

Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.

BSc in Life Science preferred

Experience in conducting and leading internal and external GCP audits for a variety of stakeholders

Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I)

Experience in conducting GCP systems audits.

Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site.

Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage.

Expert knowledge of national and international GCP legislation and guidelines

Up to 40% travel and ability to conduct remote audits

Why ADAMAS?

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

Quality: we hold ourselves to the standard patients deserve.

Integrity and trust: we do the right thing, especially when it is hard.

Drive and passion: we care about the outcome, because someone is waiting on it.

Agility and responsiveness: we move quickly, because patients cannot wait.

Belonging: everyone is welcome, and every voice counts.

Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.