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Quality Account Manager

PCI Pharma Services

PCI Pharma Services seeks a Quality Account Manager in Philadelphia to oversee quality standards and processes for a customer-focused team. The role involves managing up to 10 staff members, directing quality operations, and ensuring compliance with regulatory and cGMP requirements while driving continuous improvement.

Responsibilities

  • Recruit, train, supervise, and develop a team of 5–10 quality associates and coordinators
  • Establish team goals aligned with customer requirements and oversee performance metrics and scorecards
  • Lead investigations, corrective actions, consumer complaints, and regulatory compliance activities
  • Develop and manage Master Packaging Instructions and batch record documentation for assigned products
  • Facilitate customer audits, quarterly business reviews, and coordinate corrective actions for identified deviations

Requirements

  • Bachelor's degree and 7–10 years of related pharmaceutical or contract manufacturing quality experience
  • Demonstrated leadership and project management accomplishments in increasingly responsible roles
  • Lean, Six Sigma, or process improvement certification; black belt preferred
  • Direct regulatory inspection support and inspection experience with domestic and foreign authorities
  • Advanced proficiency in Microsoft Office suite and familiarity with GMP principles
  • Working knowledge of ICH Q9 risk-based quality guidance
  • Experience across multiple quality functions: incoming QA, operations, metrology, validation
Vacancy posted 2 days ago
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