Sr. Director, Quality Assurance

10003_1706625773
  • $190000 - $230000 per anuum
  • Pennsylvania
  • Permanent

A global contract development manufacturing organization (CDMO) is currently looking for a Senior Director of Quality Assurance to join their team. As the Sr. Director, QA you will be responsible for performance management, training, and spearhead quality improvements of the department. You'll lead a team and oversee review and disposition of production records, cleaning records, raw materials, stability and reference standards, ensuring adherence to SOPs.

Responsibilities:

  • Ensures GMP Compliance to regulatory requirements and company procedures.
  • Oversees maintenance and management of Quality Systems to ensure timely closure of Observation, Deviations, Investigations, Corrective Actions, etc.
  • Support and delegates SAP related actions necessary for the team
  • Support cell structure and associated quality team support, adjusting as necessary
  • Supports thorough Root Cause Analysis for investigations/deviations.
  • Evaluates corrective and preventive actions to ensure effectiveness.
  • Develops and supports team training materials.
  • Works with the QA Operations team to align and focus workload and priorities to meet client and site needs.
  • Performs duties in accordance with Standard Operating Procedures (SOPs).
  • Maintains quality databases and may perform analysis and trending.

Key Qualifications:

  • Strong knowledge of cGMP, SOPs, CAPAs, material controls and batch disposition procedure requirements.
  • Experience with quality systems, data integrity, change control procedures required.
  • Bachelor's degree in Chemistry, Biology, or related technical field.
  • 10+ years experience in a GMP environment required
  • Prior experience working in a CDMO preferred.

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