Lead Quality Dossier Program Auditor

The Lead Quality Dossier Program Auditor role supports the Quality Dossier Program audit process by planning and conducting audits required by the Quality Dossier Program. This includes effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process and managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.
Responsibilities:
Plan and conduct audits required by the Quality Dossier Program. Audits may be of clinical documents, pre-clinical documents, CMC documents, etc.
Perform peer reviews of document audits.
Review audit responses for adequacy, consistency, and compliance
Maintain the audit schedule
Represent RD QA for Dossier Program related meetings/activities/functions as needed.
Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
Identify and resolve problems through effective interpersonal skills.
Work independently as well as part of a team
Maintain effective communication of program related information.
Bachelor’s degree preferable in a physical science, life science, pharmacy, engineering, or equivalent experience required.
5+ years’ experience in the Medical Device or Pharmaceutical industry,
Experience in Quality Assurance or Regulatory Affairs (preferred)
Quality Assurance auditing experience (preferred)
Planning and conducting audits required by the Quality Dossier Program
Effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process.
Coordinating the review and tracking of audit responses and associated tasks across multiple dossier programs.
Managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.
Escalating potential quality issues to management
Assist in the management of Due Diligence and Post-Closure Quality Assessment activities in support of projects across one or more aspect of the business.
Assist in the coordination, review, and tracking of RDQA activities needed to complete Due Diligence and Post-Closure Quality assessments.

Employment type
Full-time

Work arrangement
No