Manager Post Market Quality Assurance F/M
Core
Act as a Site Quality representative for commercialized AbbVie products and the global supply chain, overseeing post-market surveillance, complaint management, and supplier quality strategies.
Role type
Manager, Post Market Quality Assurance
Builds
Global post-market surveillance strategy, complaint management systems, supplier quality partnerships, and quality system effectiveness.
Domain
Pharmaceutical industry, Post-Market Surveillance (PMS), Regulatory Affairs
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Post-market surveillance strategy, Periodic Safety Update Reports (PSUR) development, Post Market Clinical Follow-up (PMCF) management, complaint management, supplier quality strategy, quality system implementation, stability program management, trend reviews, audit execution, KPI monitoring, budget management, team leadership
Preferred skills
Advanced scientific degree (Master's or higher) or pharmacist qualification, 10+ years in quality assurance operations management, regulatory affairs, or technical support, knowledge of FDA and ISO13485 requirements, ability to synthesize and present information, analytical and problem-solving skills, ability to manage multiple complex tasks
Technologies
FDA regulations, ISO13485 standards
Responsibilities
Oversee and implement the global post-market surveillance strategy, manage the global complaint management strategy, oversee the supplier quality strategy, implement and maintain the quality system's effectiveness, coordinate activities related to major quality events, manage stability programs, lead the implementation of trend reviews, conduct audits and monitor KPIs, establish and manage the department budget, manage a multidisciplinary quality team
Seniority
Manager, hands-on leadership with team supervision