Conduct work as identified on the audit activity table (listing on the table is not all-inclusive but a representative sample)
Takes lead in the generation of global QA policies on the interpretation/ application of regulations.
Provide subject matter expertise and lead/influence the organization by providing guidance and client/authority-facing support on specific niche regulatory topics.
Hosts (ie, for cause inspection, non-standard authority inspections, country-specific or scope of inspection) external audits/inspections eg, 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 forums (eg, Monthly Reports, Site Quality Review, Liaison meetings).
Manage (for own area of expertise) / participate (for multi-regulatory topics) in the broad-scope global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization.
Acts as a backup for QA Manager; provides a 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 followe'd.
Other duties assigned by management.
Experience:
8 years in the regulatory environment (experience in GXP roles)
Regulatory expertise - detailed knowledge of specific regulations/ multiple regulations.
Experienced Lead Auditor.
Strategic communication with clients.
Experience leading process improvement initiatives.
Qualification:
A minimum of a bachelors degree in a Pharmacy, Chemistry or Biology related discipline.
Postgraduate degree (MSC or equivalent) in science or management-related discipline, preferable.
