Your primary focus will be to conduct External GCP Audits. You will work with some of the industries sharpest minds, and will enjoy flexibility to conduct your professional Pharmaceutical and Biotech Clinical Audits as the lead and primary auditor. To be successful in this role, you will need to have extensive experience as the lead or primary auditor conducting external sponsor audits, deep understanding of CRO auditing and excellent communication skills.
- Schedule, conduct and document assigned audits of projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to: investigator sites, trial master and project management files, data management activities and files, safety reporting, final study reports, and vendors.
- Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.
- Conduct audit debriefs with project teams and/or sponsor
- Writes and issue audit reports in accordance with standard company formats and timelines, ensuring clear communication of audit findings to the relevant project team members.
- Maintain accurate and timely documentation of QA auditing activities.
- Serve as a trainer and mentor to newly hired QA Auditors.
- Serve as Global Lead Auditor on projects as assigned.
- Maintain subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
- Participate in Trusted Process meetings such as Kick-off, Quick Start Camp, and Quality Finish Camp.
- Demonstrated initiative, uncompromised integrity and a results-oriented mindset
- Bachelor’s Degree in the science/health care field or equivalent combined education and experience
- Extensive experience in clinical quality assurance auditing (GCP)and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc.)
- Strong knowledge of all applicable Good Clinical Practice (GCP) regulations and guidelines.
- Good Manufacturing Practices (GMP) auditing experience, preferred
- Good Pharmacovigilance Practices (GVP) clinical safety and post-marketing auditing experience, preferred
- Knowledge of medical terminology preferred.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
- Strong organizational, presentation, documentation, and interpersonal skills with diverse cultures.
- Ability to negotiate and provide constructive feedback.
- The ability to travel up to 75%
- Advanced level of English language