Senior Director, Quality Engineering

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.

Essential Functions:

• 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.

Education:

• Bachelor's Degree (BA/BS) bachelor’s degree in engineering, Pharmacy, Chemistry, or related field - Required
• Master's degree (MS/MA) Advanced degree in Engineering, Pharmacy, Chemistry, or related field - Preferred

Experience:

• 15 years or more in Pharma/Biotech/Medical Device experience, with deep expertise in combination-product quality

Specialized Knowledge:

• Proven experience leading design controls, risk management, device development or manufacturing.
Successful track record managing global teams and supporting FDA/EMA inspections.

International travel up to 25% per year.

The annual salary for this position ranges from $240,000 to 265,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.