Temp - Associate Manager GCP QA Auditor

The Regeneron Associate Manager GCP QA Auditor is a key position in the Quality Assurance and Auditing group and will provide guidance and leadership for the GCP, GLP, GVP, or SUB Audit Programs and audits. This individual will create strategic partnerships and execute risk-based quality auditing activities across Global Development (GCP/GVP/SUB) or Preclinical Development (GLP).  The Associate Manager QA Auditor applies expertise in Good Clinical, Good Laboratory, and/or Good Pharmacovigilance Practice (GxP) and international regulations to the auditing process to independently address a variety of GxP compliance issues associated drug development and post-marketing authorization. The individual should have in-depth knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development and post-authorization safety monitoring including HIPAA Privacy Rule, and other international and national rules as applicable.  This individual is expected to have an in-depth level of knowledge and experience in conducting one or more audit types (e.g. process, laboratory, site, vendor, license partner, etc.), depending on the requirements of their GxP discipline.Schedules, prepares and conducts audits in support of GxP audits as directed and in accordance with Regeneron standard operating procedures and quality policies. Audits include internal audits and external audits conducted globally.

• Assembles and coordinates the activities of the audit team.
• Reports findings to management with recommendations for resolution and verifies appropriate corrective actions have been implemented and documented.
• Represents QAA on teams, compliance projects and initiatives both within and across functional areas of Global Development, PVRM, Commercial, Preclinical Development, or other departments, as applicable.
• May support clinical studies as study representative to develop and execute risk-based audit plans for assigned studies (GCP).
• Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.
• Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.
• Appropriately escalates any compliance issues.
• May assist with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
• Drafts and issues periodic reports to site management as requested
• Assist with training/orientation of new QAA staff