• Maintains current knowledge of applicable FDA regulations, ICH GCP,FDA regulations and other applicable regulatory standards to maintain effectiveness as an Clinical Affairs Auditor.
• Conducts audits independently and act as lead when multiple auditors present.
• Prepares and maintains a Division audit schedule for GCP activities, reviews and agrees to site audit schedules, plans, observations and ratings.
• Monitor and analyze both internal and external audit outcomes and react/direct/manage as appropriate.
• Participates in site-led audits of the site’s quality system, called upon as an SME during CRQS audits/regulatory inspections as well as perform activities such as scribe and/or document reviewer.
• Preparation of reports to Senior Management documenting audit activities, metrics, findings and resolutions and raise significant issues of noncompliance.
• Manage post-audit activities and follow-up on any necessary corrective and preventive actions and resolve any conflicts.
• Manage and maintain files and documentation associated with all audit activities.
• The identification/correction of GCP compliance deficiencies along with a successful facilitation of an external inspection/audit could avoid suspension of new product approvals through significant regulatory actions.
• If not prevented, this action can result in loss of business opportunities and can negatively impact the profitability of the company.
• Must have a thorough knowledge of Good Clinical Practice (GCP),ICH and FDA regulations and guidelines as must be able to interpret, explain and apply.
• Must have a proven understanding of Clinical processes and systems and experience with medical device clinical trials and substantial experience with GCP audits.
• Must have excellent organizational, interpersonal and communication skills both orally and in writing
• Experienced PC user proficient with Microsoft Word, Excel and PowerPoint.
• Proficiency in auditing databases, trial master files, investigator sites, statistical/clinical study reports, process/systems, for cause audits.
• Must be able to evaluate complex systems and determine the level of compliance to regulations and standards.
• Liaison to all appropriate Division departments/teams to ensure expeditious compilation of projects and corrective action for audit observations..
• Assist in development of training materials, manages SOPs and process improvement activities.
• Willingness to travel

Required Qualifications

• Education: Bachelor’s Degree in biology, chemistry, microbiology, or related life sciences.
• 6–8 years in Quality Assurance or clinical research.
• 3–4 years in QA/GCP auditing
• Experience with paper-based data management systems as well as EDC data management systems.
• Ability to investigate and analyze information and draw conclusions.
• Require knowledge and training in CAPA.
• Detail oriented, accurate and able to independently determine and develop approach to solutions.

Preferred Qualifications

• Certification (ASQ CQA or Lead Auditor)

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.