Senior Director, Quality Engineering

Amneal India • Piscataway, NJ

9d

About The Position

The Senior Director, Quality Engineering Combination Products, provides
strategic, technical, and quality leadership for all drug–device and
biologic–device combination products across the global portfolio. This role owns
the quality system elements required under 21 CFR Part 4, ensuring compliant
integration of drug GMP (210/211) and device QSR (820/MDR) throughout
development, manufacturing, and post-market lifecycle. The Senior Director acts
as the Quality Engineering top authority in design controls, risk management,
device quality, supplier oversight, and post-market device surveillance.

Responsibilities

• Leads and evolves the global Combination Product Quality System, including standards, policies, and processes. Ensures compliance with FDA, EMA, EU MDR, ISO 13485, ISO 14971, and applicable global regulations. Drives quality governance, risk escalation, and cross-functional alignment.
• Oversees design controls (820.30) for all device constituents, including DHF, design reviews, V&V, design transfer, and usability/human factors. Influences device architecture, system engineering, and risk-based decision making.
• Leads global ISO 14971–compliant risk management for combination products and oversee usability engineering, human factors validation, and risk mitigation strategies.
• Leads a global team of experts in design controls, risk management, device quality, and post-market quality. Builds capabilities, provide coaching, and drive a culture of innovation, accountability, and patient focus.
• Provides quality oversight of device manufacturers, component suppliers, and CMOs. Ensures robust qualification, audits, process validation, change control, and ongoing monitoring. Supports tech transfer, scale-up, and manufacturing readiness activities.
• Oversees complaint handling, device MDR/Vigilance reporting, trend analysis, and CAPA effectiveness. Partners with Drug Safety for integrated benefit-risk decisions. Leads investigations, risk assessments, and field-action decision support.
• Serves as senior subject matter expert for global health authority inspections involving combination products. Supports regulatory submissions (IND/NDA/BLA, Technical Files) with device-quality content. Leads remediation of observations related to device/combination product quality.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed