GCP Auditor (Freelance - West Coast USA)

Ergomed; California (MO); On-site; USD 90,000 - 140,000; Full time

Job summary

Ergomed Group is seeking a skilled GCP Auditor to support the execution of comprehensive GCP audits across the pharmaceutical and biotechnology sectors. The role involves planning, conducting, and reporting audits, with emphasis on regulatory compliance and patient safety.

The ideal candidate will bring extensive experience in internal and external GCP audits, comfort with service-provider audits, and the ability to coordinate inspection preparation at sponsor or investigator sites.

Qualifications

• 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.
• 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.

Responsibilities

• 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.

Skills

GCP audits

Auditing

Regulatory knowledge

Remote audits

Travel flexibility

Education

BSc in Life Science

Job description

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.