Covance by Labcorp is seeking candidates for a QA Compliance Lead Auditor. The QA Compliance Lead Auditor will be remotely located (home-based) anywhere within the United Sates.
- Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
- 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 organization
- 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.
- Regional travel essential with respect to adhering to pandemic restrictions.
- 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, preferable.
- Experience may be substituted for education.
- 8 years in regulatory environment (experience in GXP roles).
- GCP Phase II/IV experience: investigator site audits, vendors, project, process audits.
- Regulatory expertise - detailed knowledge of specific regulation/ multiple regulations.
- Experienced Lead Auditor.
- Strategic communication with clients.
- Experience leading process improvement initiatives.
Apply on company website