Apply on Employer Site

Lupin Pharmaceuticals · 2 hours ago

Quality Assurance Lead (US)

Somerset, NJ

Full-time

Onsite

Senior Level, Lead/Staff

$158K/yr - $182K/yr

8+ years exp

Lupin Pharmaceuticals is a fast-growing company focused on generic and branded drug products, including women’s health. They are seeking a Quality Systems Lead to establish and manage quality systems for drug-device combination products, ensuring compliance with regulatory requirements throughout the product lifecycle.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

Responsibilities

Design, implement, and maintain quality systems tailored to the unique needs of drug-device combination products

Ensure full alignment with FDA 21 CFR Part 820, ISO 13485, and relevant ICH guidelines

Develop and maintain procedures for design control, risk management, change control, and supplier quality oversight

Collaborate with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to embed quality into each stage of the product lifecycle

Provide quality planning and execution support to combination product teams, ensuring quality is proactively managed across disciplines

Prepare for and support both internal and external audits, ensuring all quality systems and documentation are audit-ready

Monitor regulatory changes and proactively update systems to maintain ongoing compliance with evolving standards and requirements

Author, review, and maintain Standard Operating Procedures (SOPs), quality manuals, and technical documentation

Develop and deliver training programs for cross-functional teams on the specific quality requirements for combination products

Identify and implement opportunities for process optimization and enhancements to the quality system

Lead Corrective and Preventive Action (CAPA) investigations and root cause analyses related to combination product issues

Qualification

Quality Systems DevelopmentFDA 21 CFR Part 820ISO 13485Combination Product RegulationsProject ManagementContinuous ImprovementLeadershipCommunicationCross-Functional Collaboration

Required

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

Demonstrated excellence in communication, leadership, and project management

Preferred

Prior experience establishing quality systems for combination products

Familiarity with various drug-device combination platforms

Experience working in a matrixed organization with global, cross-functional teams

Experience with women's health products or nasal delivery systems is a significant plus

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)