Associate Manager, Product Quality
Core
Lead commercial product quality activities across the product lifecycle to ensure the quality, safety, and compliance of marketed pharmaceutical, cosmetic, and medical device products.
Role type
Associate Manager, Product Quality
Builds
Product quality oversight, stability programs, complaint handling, and risk assessments for medical devices and pharmaceuticals
Domain
Medical Devices / Pharmaceuticals / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Product quality management, stability program execution, complaint investigation and trending, CAPA implementation, regulatory compliance (cGMP, FDA, ICH), cross-functional team leadership, data analysis for quality metrics
Preferred skills
Supervisory experience, mentoring and talent development, advanced degree (MA/MS), Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE)
Technologies
Quality management systems, stability study tools, regulatory reporting platforms
Responsibilities
Oversee product complaint handling, stability programs, and product quality reviews; analyze quality data to identify risks and drive continuous improvement; lead and develop a high-performing team; support regulatory and internal audits; influence cross-functional teams to address quality inquiries
Seniority
Manager, hands-on leadership with team development
