Senior QA Leader — Drug-Device Quality & Compliance

Lupin; New Jersey; On-site; USD 158,000 - 182,000; Full time

Job summary

Lupin is hiring a Quality Assurance Lead, Devices to guide quality systems and regulatory compliance for our drug-device portfolio in New Jersey. You will lead design control, risk management, change control, supplier quality oversight, and ensure alignment with FDA 21 CFR Part 820, ISO 13485, and ICH guidelines.

You will collaborate across R&D, Regulatory Affairs, Manufacturing, and Clinical teams to embed quality throughout the lifecycle and drive continuous improvement.

Qualifications

• Bachelor’s or master’s degree in engineering, Life Sciences, or a related field.
• Minimum of 8 years’ experience in Quality Assurance or Quality Systems within the pharmaceutical or medical device industry.
• Strong understanding of combination product regulations, including FDA and ISO standards.

Responsibilities

• Quality System Development and maintain quality systems for drug-device products.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to embed quality in the product lifecycle.
• Prepare for internal and external audits and maintain audit-ready documentation.
• Author, review, and maintain SOPs, quality manuals, and technical documentation.
• Identify and lead CAPA investigations and root cause analyses.

Skills

Quality systems

Cross-functional work

Regulatory compliance

Documentation

CAPA investigations

Project management

Education

Bachelor’s or Master’s in engineering or life sciences

Tools

FDA standards

ISO 13485

Job description

Lupin is hiring a Quality Assurance Lead, Devices to guide quality systems and regulatory compliance for our drug-device portfolio in New Jersey. You will lead design control, risk management, change control, supplier quality oversight, and ensure alignment with FDA 21 CFR Part 820, ISO 13485, and ICH guidelines.

You will collaborate across R&D, Regulatory Affairs, Manufacturing, and Clinical teams to embed quality throughout the lifecycle and drive continuous improvement.