A Specialty Pharmaceutical Company

Director, Enterprise Quality Auditing

DirectorDirectorFull TimeRemoteTeam 1,001-5,000H1B SponsorCompany Site LinkedIn

Location

New Jersey

Posted

25 days ago

Salary

Not specified

Bachelor Degree15 yrs expEnglishGoogle Cloud Platform

Job Description

• 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

Job 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.