Regulatory

 

  • Designs and drives Quality processes to assure GxP compliance for:
    • Disposition of drug substances and investigational medicinal products
    • Clinical Study quality audit planning, execution and resolution of issues
  • Participates in the planning and content development and review of global regulatory submissions.
  • Serves as the Quality representative on project teams and manage relationships with counterparts within Service Provider organizations.
  • Designs and oversees the execution of cGXP and SOP training programs.
  • Develops quality management budget and monitor expenditures.
  • Provides strategic direction and oversight in the development of the company’s Pharmaceutical Quality Systems.
  • Identifies cGXP and other key compliance requirements, and provide leadership in promoting awareness and understanding of global regulatory compliance expectations.
  • Develops and maintain centralized system for GXP document and record control, archival, protection and access.
  • Edits and approves standard operating procedures (SOPs) proposed from functional areas. Assure harmony across all SOPs, and shared responsibilities at functional interfaces.
  • Assures proper Service Provider qualification (and disqualification).
  • Leads the Internal Audit Program process, including assessment of internal and external (or outsourced) cGXP operations.
  • Provides leadership across cross-functional areas, and ensure that drug development activities are conducted and data are generated, documented, reported and maintained in compliance with cGXP requirements.
  • Makes recommendations for improvement of product quality and quality system efficiency.

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