Director, Enterprise Quality Auditing
Endo
full-time
Posted on:
Location Type: Remote
Location: New Jersey • United States
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Job Level
Tech Stack
About the role
- Overseeing and directing both the US and EU teams who are responsible for the global external Quality auditing program
- Overseeing and directing the collection, collation, analysis and publication of audit reports, observations, responses and Corrective and Preventative Actions from the External Manufacturing Inspection programs
- Maintaining current and implementing new Quality Management Systems to support the Enterprise Auditing Function
- Recruiting, training, developing, coaching, and directing a team of professional auditors
- Support the Endo enterprise as a compliance SME
Requirements
- Minimum of a BA/BS with a minimum of 15 years or longer experience in a pharmaceutical manufacturing or Quality Assurance/Compliance environment
- A minimum of 10 years auditing experience associated with a wide range of Pharmaceutical Manufacturing Environments across multiple countries
- Demonstrated effective people management and development experience
- ASQ-CQA or ASQ-CQE certified highly desired
- Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc
- Proficiency in a body of information required for the job e.g., knowledge of current and emerging quality/compliance regulations across multiple jurisdictions (e.g., cGMP, GLP, ICH guidelines and guidance documents)
- Knowledgeable of and familiar with current IT based Quality systems.
Benefits
- Health insurance
- Competitive salary
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
auditingQuality Management Systemscompliance regulationsGMPGLPGCPLean ManufacturingSix-SigmacGMPICH guidelines
Soft Skills
people managementteam developmentcoachingtrainingleadership
Certifications
ASQ-CQAASQ-CQE