Team Lead/Director Quality Assurance
Core
Design, operate, and improve the quality system for pharmaceutical products and active ingredients, ensuring compliance with regulations and managing risks.
Role type
Director/Team Lead Quality Assurance (Pharma/Biopharma)
Builds
Quality systems, SOPs, CAPA processes, and regulatory compliance frameworks for drug products. (via careerplan.io/jobs/f3db6f2a-95b7-4bd1-bd8e-81e0508ee0bf-team-leaddirector-quality-assurance-at-vertanical)
Domain
Biopharma / Pharmaceutical Quality Assurance
Required skills
Quality system development, SOP creation, Change management, Deviation management, CAPA, Regulatory compliance (GMP/GDP), Audit preparation, Team leadership, Risk assessment, Stakeholder coordination
Preferred skills
Strategic planning, Root cause analysis, External partner qualification, Data analysis for quality trends
Technologies
GMP, GDP, AMG, HWG, SGB, AM-RL, CAPA systems
Responsibilities
Develop and maintain quality systems and processes; Coordinate batch release and external inquiries; Act as liaison for national and international regulations; Evaluate quality events and trends; Prepare for regulatory inspections and audits; Qualify external partners; Report compliance status and risks to executive leadership
Seniority
Director/Team Lead, strategic oversight and team management