Manager, Quality Assurance
Core
Manages quality programs, policies, and operational procedures to ensure product compliance with regulatory standards and supply chain integrity for private label pharmaceutical products.
Role type
Manager, Quality Assurance (Pharmaceuticals)
Builds
Compliant and cost-effective quality systems for Cardinal Health private label pharmaceutical product lines.
Domain
Healthcare / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/cGDP regulatory knowledge, change control management, complaint intake processing, root cause analysis, CAPA development, SOP authoring and review, team leadership, cross-functional stakeholder management, Veeva Vault eQMS proficiency, pharmacovigilance data collection.
Preferred skills
Bachelor's degree in related field, 8+ years of experience in quality assurance.
Technologies
Veeva Vault Electronic Quality Management System (eQMS)
Responsibilities
Supervise Quality Assurance Specialists and manage department operations; oversee complaint intake, triage, and processing for private label portfolios; manage change controls (temporary, emergency, and standard) within Veeva Vault; develop and execute quality policies and procedures; lead cross-functional teams to resolve complex quality issues; ensure adherence to 21 CFR Parts 207, 208, 210, 211, and 820 guidelines.
Seniority
Manager, hands-on leadership
