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About the Role
ADAMAS Consulting partners with pharmaceutical and biotechnology companies to ensure the highest standards of quality, compliance, and patient safety through GCP audits and quality assurance projects. This role involves planning, executing, and reporting on various GCP audits, contributing to client risk mitigation and patient safety.
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.
Requirements
- 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.
- Ability to conduct remote audits.
Skills
- GCP audits
- Quality assurance
- Regulatory requirements
- Good Clinical Practice (GCP)
- Service provider audits
- Systems audits
- Inspection preparation
- Mock inspections
- GCP legislation and guidelines
Location
- Remote
Work Type
- Full-time
- Travel up to 40%
Experience Level
- Senior
Education Level
- BSc in Life Science preferred
About the Company
- 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.
- 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.
- 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.
- Our values are Quality, Integrity and trust, Drive and passion, Agility and responsiveness, Belonging, and Collaborative partnerships.