Manager Compliance Auditing
Pharmaceutical Manufacturing
St. Louis, MO


Global leader in the development and production of life saving pharmaceuticals seeks a Manager of Compliance Auditing to direct audit activities at various company sites, including R&D and manufacturing.  The Manager of Compliance Auditing will:

• ·      Provide leadership to a group of compliance auditors
• ·      Develop and manage annual audit program
• ·      Develop and manage audit schedules, readiness audits prior to regulatory agency inspections
• ·      Perform focused audits, including internal and supplier
• ·      Maintain supplier audit schedule
• ·      Monitor and report audit trending metrics to site and corporate management

Requirements:

• ·      Bachelor’s degree in a technical discipline; chemistry, biology, engineering, math
• ·      7+ years experience in quality assurance in pharmaceutical or medical device manufacturing
• ·      5+ years of audit experience
• ·      Experience in aseptic pharmaceutical manufacturing strongly preferred
• ·      CQA certification strongly preferred
• ·      Formal training or certification in compliance auditing and quality systems required
• ·      API and medical devices experience a plus
• ·      Strong working knowledge of international, FDA regulations and ICH guidelines for drug and medical device manufacturing
• ·      Strong project management skills and the ability to simultaneously manage multiple projects
• ·      Travel expected to be 25-50%, domestic and international

Candidates should submit resumes in WORD.

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