associate manager Quality AssuranceCovance

Job Overview:
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
Education/Qualifications:
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
Experience:
4 years CRO/Pharmaceutical experience
3 years in a GXP quality role, including at least 1 year in a GCP quality role required
Covance

Manila City, Metro Manila
Permanent
Full-time