GMP Auditor (Freelance)

ADAMAS Consulting; Raleigh (NC); Hybrid; USD 85,000 - 100,000; Full time

Job summary

ADAMAS Consulting is seeking an experienced GMP Auditor to join our team in Raleigh. You will plan, perform, and report GMP audits for pharmaceutical clients, ensuring compliance with global standards and timelines.

The role requires coordinating inspection prep, travel up to 40%, and ability to conduct remote audits when needed. BS in Life Science preferred; prior internal/external GMP auditing is a plus.

Qualifications

• Experience in conducting and leading internal and external GMP audits.
• Experience in coordinating and managing inspection preparation activities for GMP process inspections.
• Strong understanding of current regulatory standards and GMP guidelines.
• BS in Life Science preferred.

Responsibilities

• Planning, preparation, conduct, reporting and follow up of GMP audits according to quality and timelines.
• Executing audits based on GMP requirements and regulatory standards.
• Performing GMP quality assurance projects for pharmaceutical/biotechnology clients.

Skills

GMP audits

Audit management

Education

BS in Life Science

Job description

Company 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.

Job Description

• Planning, preparation, conduct, reporting and follow up of various types of GMP audits according to expected quality and timelines
• Executing audits based on a comprehensive understanding of all regulatory requirements and Good Manufacturing Practice (GMP)
• Performing GMP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.

Qualifications

• Experience in conducting and leading internal and external GMP audits for a variety of stakeholders
• Experience in conducting a range of service provider audits would be an advantage (e.g., API manufacturers, CMOs)
• Experience in coordinating and managing inspection preparation activities for GMP process inspections both at the sponsor and investigator site.
• Experience and full understanding of current applicable regulatory standards.
• Expert knowledge of national and international GMP legislation and guidelines
• Proficient in managing projects and ensuring deliverables are provided in a timely manner
• Ability to identify issues and offer solutions in a pragmatic way
• BS in Life Science preferred
• Up to 40% travel and ability to conduct remote audits

Additional Information

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.