The Associate Manager Quality Assurance is responsible for leading internal, external, regional and global 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.
- Lead 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
- Leads complex audits (e.g., directed, process, systems, office)
- Provide 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
- Proactively identifies and leads process improvement activities / SOP creation and revisions
- Able to host client audits and able to support regulatory inspections
- Leads and/or pmticipates in special projects
- Represents Audit QA on project teams and other internal forums
- Trains and mentors junior QA Audit staff/ support on-boarding of new personnel
- 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
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