Job Title: GCP Auditor Consultant

Description: The Senior GCP Auditor Consultant will play a critical role in ensuring compliance with Good Clinical Practice (GCP) guidelines across all clinical trials conducted. This individual will be responsible for planning, conducting, and reporting on GCP audits to ensure the integrity and quality of clinical data and safety of trial participants. The ideal candidate will have extensive experience in GCP auditing, a thorough understanding of regulatory requirements, and a strong background in clinical research.Key Responsibilities:

• Plan, schedule, and conduct GCP audits of clinical sites, vendors, and internal processes to ensure compliance with GCP, ICH guidelines, and regulatory requirements.
• Develop and maintain audit plans, checklists, and reports, ensuring they are comprehensive and up-to-date with current regulations and industry best practices.
• Identify and document audit findings, including deviations, deficiencies, and areas for improvement, and work with relevant stakeholders to develop and implement corrective and preventive actions (CAPAs).
• Provide expert guidance and support to clinical teams on GCP compliance, regulatory requirements, and quality assurance best practices.
• Conduct follow-up audits to verify the implementation and effectiveness of CAPAs.
• Stay current with industry trends, regulatory updates, and emerging best practices in GCP and clinical research.
• Participate in the development and revision of Standard Operating Procedures (SOPs) related to clinical quality and GCP compliance.
• Collaborate with cross-functional teams to support continuous improvement initiatives and promote a culture of quality and compliance throughout the organization.
• Prepare and present audit findings and compliance reports to senior management and other stakeholders.

Qualifications:

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. Advanced degree preferred.
• Minimum of 12 years of experience in clinical research, with at least 7 years of experience in GCP auditing.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements (e.g., FDA, EMA).
• Proven track record of conducting a wide range of GCP audits, including investigator sites, CROs, and internal processes.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills, with the ability to effectively present complex information to diverse audiences.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
• Certification in GCP auditing (e.g., ASQ CQA, RQAP-GCP) is highly desirable.