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Covance Senior Auditor, Audit & Inspection Management in Boston, Massachusetts

Job Overview:

Covance is seeking candidates for a Senior Auditor, Audit & Inspection Management. The Senior Auditor, Audit & Inspection Management can be home based within the United States.

This role is responsible for leading internal and external QA audits per Standard Operating Procedures and Master Audit Plan, assuring that audited systems, processes and their outcomes comply with applicable international and national regulations and guidelines, and fulfill client and Covance requirements. The position assures that audits assigned are completed on time and within budget, including audit reporting and CAPA follow up and closure.

Duties:

  • Leads audit teams in the conduct, reporting and follow up of regional and local QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards

  • Conducts complex, directed, and/or time sensitive QA audits

  • Participates in global QA audits

  • Provides suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure; Escalates, as appropriate, where resolution of audit findings is inadequate

  • Leads process improvement activities/SOP creation and revision

  • Able to support client audits and regulatory inspections

  • Leads and/or participates in special projects

  • Represents Audit QA on project teams and other internal forums

  • Trains and mentors junior staff

  • Travel up to 50% with respect to any pandemic-related restrictions

Education/Qualifications:

  • University/college degree BA/BS (life science preferred) or equivalent experience

  • Knowledge, understanding, and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs

  • Knowledge of the drug development process from the perspective of a contract research organization

Experience:

Minimum Required:

  • 4 years CRO/Pharmaceutical experience

  • 3 years in a GXP quality role, including at least 1 year in a GCP quality role required

Preferred:

  • Medical device experience

  • Oncology therapeutic area experience

  • Phase II to IV experience

  • Ability to read and speak Spanish

#LI-REMOTE

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

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