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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 findings

+ Provide oversight to supplier quality management process

+ Conduct supplier audits including on-site inspections when required

+ Maintain a history of audits performed and schedule repeat audits as required

+ Coordinate and manage supplier quality alerts

+ Coordinate and participate in regulatory and customer audits

+ Perform trending of audit findings and identify opportunities for improvement

+ Maintain current knowledge of regulations and guidance documents

+ Manage and mentor audit personnel

Qualifications:

+ Four year college degree in Pharmacy, Chemistry, Biology or related field

+ 5-10 years’ experience in the pharmaceutical industry with a quality background

+ Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance

+ ASQ Certified Quality Auditor required

+ Experience with FDA audits

+ Proficient with current word processing and database software

+ Strong interpersonal/group skills with ability to motivate and direct others

+ Strong communication skills, verbal and written

Qualifications

Qualifications:

+ Four year college degree in Pharmacy, Chemistry, Biology or related field

+ 5-10 years’ experience in the pharmaceutical industry with a quality background

+ Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance

+ ASQ Certified Quality Auditor required

+ Experience with FDA audits

+ Proficient with current word processing and database software

+ Strong interpersonal/group skills with ability to motivate and direct others

+ Strong communication skills, verbal and written