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Endo logo
Endo

A Specialty Pharmaceutical Company

Director, Enterprise Quality Auditing

DirectorDirectorOtherRemoteLeadTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

New Jersey

Posted

124 days ago

Salary

0

Seniority

Lead

Bachelor Degree15 yrs expEnglishGCP

Job Description

Director, Enterprise Quality Auditing

Endo

• 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.

Benefits

  • Health insurance
  • Competitive salary
  • Flexible work arrangements
  • Professional development opportunities

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