Quality Assurance Auditor

No Corp to Corp (C2C) candidates. Only candidates who can work directly on W2 will be considered.

The primary responsibility of this role is to provide oversight of GCP activities which include, but are not limited to: ensuring patient safety, data integrity and compliance with SOPs, GCP and applicable regulations. Additional responsibilities include execution of the GCP Audit Plan as well as support of Inspection Management goals and objectives

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  Responsibilities:Plan, conduct or manage, and report results for GxP audits which includes but is not limited to internal processes, clinical investigational sites, clinical vendors, CSRs and TMF
• s.Train, coach and oversee Clinical QA personnel, subject matter experts (SMEs) and/or other contract service provider(s) in preparing, conducting, and reporting of GxP audits, as assign
• edActively support inspection readiness activities, associated Health Authority Inspections and perform assigned War Room leadership role through the followin
• g:Participate in cross functional teams to identify GxP inspection risks and lead activities to mitigate and defend business processes, for example through storyboard proce
• ssIdentify and communicate potential ris
• ksDevelop and deliver inspection training for SMEs and War Room support team membe
• rsLead partnerships with key stakeholders to deliver forward-thinking programs and training facilitating a state of inspection readine
• ssReview GCP-associated controlled documents which may include standard operation procedures (SOPs), protocols/amendments, study-specific documents such as study or data management plans, etc., in accordance with applicable regulatory requirements (e.g., ICH E6, U.S. FDA, EMA, and local regulation
• s)Provide guidance and support to internal departments and Clinical Study teams (during all phases of clinical development) in the identification and investigation of potential GCP and compliance issues, including those at clinical investigator sites, with internal processes, and with vendors conducting GCP activitie
• s.Ensure appropriate and timely solutions for corrective and preventive actions are implemented at sites or vendors, when needed to secure compliance and maintain a state of inspection readines
• s.Ensure proper evaluation and completeness of deviation/CAPA entries; project manage process to ensure timely completion and closure of deviations/CAPAs, to ensure triage and report metrics and trends to managemen
• t.Perform any other tasks as requested by Clinical QA and/or Executive Management to support Quality oversight activiti
• esRequirements / Qualifications:Bachelor's Degree is required in a scientific or related technical discipli
• neAt least 7 years’ experience in Biotech/Pharmaceutical industry, Quality Assurance experience preferr
• edStrong working knowledge and interpretation of global GCPs, particularly U.S. FDA / EU and ICH regulations and guidelin
• esAble to execute quality goals over a 1-2 year period that aligns to company-wide objective
• s.Excellent communications skills, both written and verb
• alFlexible in the face of shifting needs and/or prioriti
• esMotivated, committed and self-manag
• edTravel up to 30% of the ti