Senior Process Quality Excellence Specialist

A global pharmaceutical company is looking to hire a Senior Process Quality Excellence Specialist on an initial 12 month contract. Working on global study specific activities within a growing team, you will bring comprehensive Regulatory Intelligence experience and will successfully manage the RIN requirements for Global Clinical Safety Operations.

• Become the Regulatory Intelligence coordinator to work with the relevant SMEs for regulatory/guidance requirements to controlled documents.
• Review regulations and identify which SMEs should be assigned based on the topic
• Act as a point of contact to confirm that CROs have assessed regulatory and country regulations that may impact their SOPs and clinical studies.
• Act asTags:
  Audit Host - work with the Auditing team to host and coordinate with relevant SMEs and functions on any internal Quality Audit.
• Act as a point of contact and co-ordinator with the auditing team.
• During the audit, assist the assigned SMEs in responding to queries by the auditees. Post-audit, work with the SMEs on responses to findings, CAPAs, etc., until the audit is closed.