Audit Manager

The Audit Manager is responsible for the internal audit program, supplier quality management and coordination/execution of customer and regulatory audits.Responsibilities:Ensure execution of internal audits according to the Internal Audit Master Plan Track the execution of corrective action implementation of audit findingsProvide oversight to supplier quality management processConduct supplier audits including on-site inspections when requiredMaintain a history of audits performed and schedule repeat audits as required Coordinate and manage supplier quality alertsCoordinate and participate in regulatory and customer auditsPerform trending of audit findings and identify opportunities for improvementMaintain current knowledge of regulations and guidance documentsManage and mentor audit personnelQualifications:Four year college degree in Pharmacy, Chemistry, Biology or related field5-10 years’ experience in the pharmaceutical industry with a quality background Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and complianceASQ Certified Quality Auditor requiredExperience with FDA auditsProficient with current word processing and database softwareStrong interpersonal/group skills with ability to motivate and direct othersStrong communication skills, verbal and writtenQualificationsQualifications:Four year college degree in Pharmacy, Chemistry, Biology or related field5-10 years’ experience in the pharmaceutical industry with a quality background Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and complianceASQ Certified Quality Auditor requiredExperience with FDA auditsProficient with current word processing and database softwareStrong interpersonal/group skills with ability to motivate and direct othersStrong communication skills, verbal and written