Conduct work as identified on the audit activity table related to CDCS (listing on table is not all inclusive but a
Takes lead in generation of global QA policies on interpretation/ application of regulations
Provide subject matter expertise and leads/influences the ED/CS/CDS/CLS organization by
providing guidance and client/authority facing support on specific niche regulatory topics
Hosts (i.e. for cause inspection, non-standard authority inspections, country-specific or scope
of inspection) external audits/inspections e.g. regulatory inspections, strategic clients.
Facilities and reviews responses to the audit.
Leads the reporting of quality metrics and implementation of necessary corrective actions
and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality
Review, Liaison meetings).
Manage (for own area of expertise) / participate (for multi-regulatory topics) in broad scope
global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA
Acts as a backup for QA Manager; provides monthly report of activities to QA Manager;
performs other related duties as assigned
Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated
in applicable controlled documents, are followed
Other duties as assigned by management.
A minimum of a Bachelor's Degree in a Pharmacy, Chemistry or Biology related discipline
Postgraduate degree (MSC or equivalent) in science or management related discipline,
Experience may be substituted for education.
8 years in regulatory environment (experience in GCP roles)
Regulatory expertise - detailed knowledge of specific regulation/ multiple regulations
Experienced Lead Auditor
Strategic communication with clients
Experience leading process improvement initiatives