QA Lead – Drug-Device Quality & Compliance

Lupin; Northern (KY); Hybrid; USD 158,000 - 182,000; Full time

Benefits offered by this job

Discretionary performance bonus

Equal opportunity employer

Job summary

Lupin is seeking a Quality Assurance Lead, Devices to drive quality systems and compliance for drug-device products. You will lead design controls, risk management, change control, and supplier quality oversight, collaborating with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to embed quality through the lifecycle.

The role requires 8+ years in QA/QS in pharma or medical devices, strong regulatory knowledge, and a capability to lead audits and continuous improvement.

Qualifications

• Minimum 8 years’ experience in Quality Assurance or Quality Systems within pharma or medical device industry.
• Strong understanding of combination product regulations including FDA and ISO standards.
• Experience with women’s health products or nasal delivery systems is a plus.

Responsibilities

• Develop, implement, and maintain quality systems for drug-device combination products.
• Ensure alignment with FDA 21 CFR Part 820, ISO 13485, and ICH guidelines.
• Lead CAPA investigations and root-cause analyses.
• Prepare for audits and ensure documentation is audit-ready.

Skills

Quality System Development

Regulatory compliance

CAPA investigations

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in Engineering/Life Sciences or related field

Job description

Lupin is seeking a Quality Assurance Lead, Devices to drive quality systems and compliance for drug-device products. You will lead design controls, risk management, change control, and supplier quality oversight, collaborating with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to embed quality through the lifecycle.

The role requires 8+ years in QA/QS in pharma or medical devices, strong regulatory knowledge, and a capability to lead audits and continuous improvement.