Job Description

The Pharmaceutical 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

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