QA Lead, Drug-Device Quality Systems & Compliance

Lupin Pharmaceuticals, Inc.

New Jersey

On-site

USD 158,000 - 182,000

Full time

3 days ago

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Job summary

Lupin Pharmaceuticals, Inc. in New Jersey is seeking a strategic Quality Assurance Lead, Devices to oversee quality systems for drug-device combinations, ensure FDA/ISO compliance, and drive a culture of quality across the product lifecycle.

The role requires strong leadership, project management, and collaborative skills to partner with R&D, Regulatory Affairs, Manufacturing, and Clinical teams, with emphasis on CAPA, audits, and continuous improvement while supporting development and

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.
Experience with women’s health products or nasal delivery systems is a significant plus.
Demonstrated excellence in communication, leadership, and project management.

Responsibilities

Quality System Development across drug-device products.
Cross-Functional Collaboration with R&D, Regulatory Affairs, Manufacturing, and Clinical teams.
Compliance & Audit Readiness including internal and external audits.
Documentation & Training via SOPs, quality manuals, and technical documentation.
Continuous Improvement through CAPA investigations and root cause analyses.