Site Conformance Specialist

Location: Marietta, PA
Department: Azzur IT, LLC

Job Description

We at Azzur Group are looking for a Site Conformance Specialist to join our Azzur Consulting: Philadelphia team. This role will be focused on the assessment of all client site changes for regulatory impact and coordination of all client site regulatory submissions.

  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, and industry practice.
  • Single point of contact between all Regulatory Affairs functions and client site.
  • Site regulatory expert – responsible for interpretation of regulatory requirements and advice regarding regulatory conformance.
  • Responsible for assessing all client site change controls for Regulatory impact and for assessment (with Regulatory Affairs) of the level of change for change controls with regulatory impact.
  • Responsible for planning all client site regulatory applications following the Vaccines Regulatory Submission Building process and responsible for the internal review and approval of CMC dossiers business process outlined by LSOP 9000040603.
  • Responsible for planning and coordinating all responses to Regulatory information requests and the business process outlined by LSOP 9000040605, provide CMC and regulatory file information to the site.
  • Responsible for organizing and coordinating the actions of teams responsible for preparing regulatory submissions so that regulatory submissions are prepared accurately, completely, and on time.
  • Responsible for local coordination of license renewal requests.
  • Responsible for maintaining the Core Files and the Site Master File.
  • Member of the local inspection team during regulatory inspections.
  • Bachelor of Science of Bachelor of Arts or equivalent work experience.
  • 5 years in Quality Assurance or Regulatory Affairs in a pharmaceutical industry regulatory agency.
  • An understanding of scientific, operations management, and regulatory theory and good writing skills are essential to the role.
  • Ability to build and maintain a network with a function located outside the site at which the position is located.
  • Working knowledge of US FDA, EU, Health Canada, and WHO regulations for vaccine manufacturing.
  • Working knowledge of electronic submission processes.

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