GCP Auditor (Freelance)

About ADAMAS Consulting

ADAMAS Consulting supports major pharmaceutical and biotechnology organizations worldwide in maintaining superior quality, compliance, and patient safety standards. Established in 2007, the company delivers expertise across areas including GCP, GVP, GMP, GLP, and Computer Systems Compliance. ADAMAS values insightful, independent thinking and deep experience to help clients identify critical compliance risks and prevent patient-impacting issues. The company fosters a collaborative environment that encourages professional development and allows employees to influence the life sciences sector working alongside respected industry leaders.

Key Responsibilities

• Plan, prepare, execute, report, and follow up on various GCP audits ensuring adherence to established quality standards and deadlines.
• Conduct audits thoroughly based on a well-rounded knowledge of all regulatory requirements and Good Clinical Practice guidelines.
• Carry out GCP quality assurance projects for clients within the pharmaceutical and biotech industries.

Required Qualifications and Experience

• Preferably hold a Bachelor of Science degree in Life Sciences.
• Demonstrable experience in leading and performing both internal and external GCP audits for diverse stakeholders.
• Proven ability to conduct audits of various service providers including full-service CROs, biostatistics units, data management, and phase I trial units.
• Experience in performing GCP systems audits.
• Skilled in coordinating and managing inspection preparations for GCP process inspections at sponsor and investigator sites.
• Experience conducting GCP mock inspections meeting Competent Authority standards considered a distinct advantage.
• Comprehensive understanding of both national and international GCP laws and guidelines.
• Willingness and ability to travel up to 40%, including remote audit execution.

Additional Information

Being part of the Ergomed Group, ADAMAS offers the chance to make a meaningful contribution by ensuring safe and effective pharmaceutical treatments reach patients globally. The organization values quality, integrity, passion, agility, inclusivity, and collaborative partnerships — qualities that define its working culture and unite its diverse team.