Quality Assurance Lead (US)

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.We are seeking an experienced Quality professional to serve as the Quality Systems Lead for drug-device combination products. This pivotal role will focus on the establishment, implementation, and ongoing management of robust quality systems, with specific attention to projects such as unit dose nasal spray delivery and women’s health drug-device combination products. The Quality Systems Lead will ensure compliance with global regulatory requirements and industry best practices throughout the product lifecycle, from development through commercialization.Quality System DevelopmentDesign, 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.Cross-Functional CollaborationCollaborate 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.Compliance & Audit ReadinessPrepare 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.Documentation & TrainingAuthor, 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.Continuous ImprovementIdentify 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.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.Preferred ExperiencePrior 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.This is an exciting opportunity for a quality-driven leader passionate about advancing patient-centric drug-device combination products and ensuring the highest standards of compliance and operational excellence.The anticipated salary range for this position inNew Jersey is $158,000.00 - $182,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.Physical RequirementsThe physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.Search Firm Representatives Please Read CarefullyLupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails

Created: 2025-11-21