Quality Assurance Project Leader

2 weeks ago


New Haven, Connecticut, United States Integrated Resources, Inc ( IRI ) Full time

Position: Quality Assurance Project Leader

Company: Integrated Resources, Inc (IRI)

Job Overview:

The Quality Assurance Project Leader is responsible for overseeing the management of procedural documentation processes within the organization.

Key Responsibilities:

  • Lead the development, revision, harmonization, implementation, and upkeep of procedural documentation, including standard operating procedures and work instructions.
  • Oversee the lifecycle management of procedural documents to ensure compliance and readiness for inspections.
  • Collaborate with subject matter experts to identify necessary updates or enhancements to procedural documentation in response to regulatory changes or audit findings.
  • Support the creation of new documentation as needed, ensuring alignment with regulatory standards and operational efficiency.
  • Manage the approval, posting, and training cycles associated with procedural documentation.
  • Drive process improvements and the adoption of best practices across the organization.
  • Maintain a comprehensive understanding of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.

Qualifications:

  • Bachelor's Degree in a relevant field.
  • A minimum of 2 years of experience in managing procedural documentation.
  • Familiarity with clinical trial operations and related systems.
  • Experience with project management tools and compliant document management systems.

Preferred Qualifications:

  • Experience in project management and inspection readiness.
  • Knowledge of electronic signature processes and continuous improvement methodologies.
  • Strong understanding of drug development processes and ICH-GCP practices.


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