Senior Manager Plant Quality

PAI Pharma

Greenville, SC, US
**
Cgmp and fda/dea regulatory compliance
Supervision of qa personnel and operations
Batch record review and product disposition
** PAI Pharma is seeking a Senior Manager Plant Quality in Greenville, SC, responsible for overseeing quality assurance activities to ensure regulatory compliance and product safety. The ideal candidate should have a relevant degree and management experience, coupled with strong skills in quality assurance processes within a pharmaceutical environment. **

Job Summary

  • The role involves planning and supervising daily quality assurance operations to ensure regulatory compliance and product safety in an FDA/DEA regulated environment.
  • Responsibilities include reviewing batch records for accuracy, managing non-conforming materials, and leading investigations into exceptions and customer complaints.
  • The position requires mentoring QA personnel, maintaining training records, and supporting validation activities while ensuring security of controlled substances.

Matching Summary

Match Score: 75

** PAI Pharma is seeking a Senior Manager Plant Quality in Greenville, SC, responsible for overseeing quality assurance activities to ensure regulatory compliance and product safety. The ideal candidate should have a relevant degree and management experience, coupled with strong skills in quality assurance processes within a pharmaceutical environment. **

Skills & Requirements

Must-have

  • cGMP and FDA/DEA regulatory compliance
  • Supervision of QA personnel and operations
  • Batch record review and product disposition
  • Statistical based sampling plans application
  • Investigation of exceptions and non-conformances

Nice-to-have

  • ASQ Certification preferred
  • Experience with Warehouse Management Systems
  • Leadership in continuous improvement initiatives
  • Proficiency in statistical process control systems

Key Requirements

  • Four-year college degree or equivalent experience
  • 3 years related experience plus 3 years management experience
  • Intermediate computer skills including MS Office

Work Rights

Not specified

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