Supports the development of robust quality systems in QA
Scopes and leads complex audits (e.g., directed, process, systems, office)
Leads audit teams in the conduct, reporting and follow up of regional and global QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
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
Provides QA support to internal business partners
Proactively identifies and leads process improvement activities / SOP creation and revision
Able to host client audits and co-host regulatory inspections
Leads and/or participates in special projects
Represents Audit QA on project teams and other internal forums
Trains and mentors junior QA Audit staff / suppolt onboarding of new personnel
Responsible for providing subject matter expertize to RCQA and business partners
Trains and mentors new and less experienced audit staff
Proactively identifies and interprets changes in regulatory environment
Prepares overviews of audit findings for presentation to management. Assists in the analyses for trend and signal detection.
Thank you University/college degree BA/BS or equivalent (Life sciences preferred)
Thorough 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 from the CRO's or a sponsor's perspective
Minimum 9 years CRO/Pharmaceutical experience and 8 years in a GXP quality role, including at least 6 years in a GCP quality role required
Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.
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