Quality Account Manager
Core
Lead a Customer Focused Team to ensure quality products and processes align with site standards for biopharma clients.
Role type
Senior Quality Account Manager (Team Lead)
Builds
Quality products and processes for biopharma companies
Domain
Biopharma / Quality Assurance / cGMP
Required skills
Team leadership and development, Project management, Quality risk assessment (FMEA, HCCAP, QbD), Regulatory compliance (cGMP, ICH Q9), Batch record management, CAPA management, Budgeting
Preferred skills
Lean Six Sigma Black Belt, Experience with regulatory inspections
Technologies
Microsoft Project, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
Responsibilities
Select, supervise, coach, and develop a team of 5-10 associates; Establish team goals aligned with customer requirements; Facilitate daily team performance and continuous improvement; Manage customer audits, visits, and corrective actions; Oversee batch records and Master Packaging Instructions; Collaborate on Quarterly Business Reviews; Drive process improvements to reduce errors and overdue CAPAs.
Seniority
Senior, hands-on IC with supervisory responsibilities