Job Description
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
Job Tags