The GCP Auditor at Soligenix will report directly to the VP, Project Management & Regulatory Affairs and lead the GCP Quality Oversight of Soligenix’s clinical programs. The Auditor will be well versed in GCP requirements and have an extensive history auditing clinical sites participating in Phase 3 registration studies planned to be used as the basis for international marketing applications.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Organizing, coordinating and performing GCP (Good Clinical Practice) related audits in relation to all GCP regulated activities.
- Audits will include those taking place at Soligenix HQ/offices/sites, at vendors, licensed/business partners and investigator sites.
- Supporting the development and maintenance of Soligenix's audit strategy and programs in line with GCP and in conjunction with related management functions.
- Supporting the organization in quality management projects, implementation and follow-up of Corrective and Preventive Actions.
- Providing QA guidance in defining audit strategy, scope, report and associated actions.
- Represent QA in appropriate and assigned task forces.
- Preparing for and/or participating in regulatory health authority inspections. Contributing to further developing Soligenix's internal Quality Management System (QMS).
- Leads audits/quality control verifications of key clinical/regulatory documents including IND and clinical trial applications submissions (as needed), clinical study reports, Investigator’s Brochure, etc.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Minimum of BA/BS degree in Life Sciences.
YEARS OF EXPERIENCE:
- At least 5 years of experience in GCP auditing and at least 8 years of industry experience.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
OTHER SKILLS AND ABILITIES:
- An advanced attention to detail and excellent written communications skills are a must.
- Open to new challenges, reliable, flexible and able to work independently.
- Experience working with software tools used in clinical development.
- Strong, professional interpersonal skills including ability to communicate effectively with people individually and in groups.
- Ability to communicate with technical and non-technical colleagues.
- Knowledge/awareness of FDA, EU GMP, GLP, ICH regulations and industry best practices.
- Knowledge/awareness of cGMPs, GCPs and/or GLPs and ICH Guidance.
- Knowledge of records and data management; best practices, tools and technology support systems.
- Experience with biologics and vaccines a plus.
Job Type: Full-time
- Industry: 8 years (Preferred)
- GCP auditing: 5 years (Required)