Covance Senior Auditor, Audit & Inspection Management in Dallas, Texas
Covance is seeking candidates for a Senior Auditor, Audit & Inspection Management. The Senior Auditor, Audit & Inspection Management can be home based within the United States.
This role is responsible for leading internal and external QA audits per Standard Operating Procedures and Master Audit Plan, assuring that audited systems, processes and their outcomes comply with applicable international and national regulations and guidelines, and fulfill client and Covance requirements. The position assures that audits assigned are completed on time and within budget, including audit reporting and CAPA follow up and closure.
Leads audit teams in the conduct, reporting and follow up of regional and local QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
Conducts complex, directed, and/or time sensitive QA audits
Participates in global QA audits
Provides suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure; Escalates, as appropriate, where resolution of audit findings is inadequate
Leads process improvement activities/SOP creation and revision
Able to support client audits and regulatory inspections
Leads and/or participates in special projects
Represents Audit QA on project teams and other internal forums
Trains and mentors junior staff
Travel up to 50% with respect to any pandemic-related restrictions
University/college degree BA/BS (life science preferred) or equivalent experience
Knowledge, understanding, and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
Knowledge of the drug development process from the perspective of a contract research organization
4 years CRO/Pharmaceutical experience
3 years in a GXP quality role, including at least 1 year in a GCP quality role required
Medical device experience
Oncology therapeutic area experience
Phase II to IV experience
Ability to read and speak Spanish
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.