Quality Assurance Lead, Devices

Quality Assurance Lead, Devices

Job Description

Lupin is seeking a strategic and results-driven Quality Assurance Lead, Devices to lead quality systems and compliance activities for our growing portfolio of drug-device combination products. In this critical role, you will establish and maintain robust quality management systems, ensure adherence to FDA and global regulatory standards, and collaborate with cross-functional teams throughout the product lifecycle. The successful candidate will combine deep quality expertise with strong leadership, project management, and communication skills to drive a culture of quality, compliance, and continuous improvement while supporting the successful development and commercialization of innovative healthcare solutions. This role will be responsible for ensuring compliance with FDA, ISO 13485, ICH, and other applicable regulatory requirements.

• Quality System Development
• 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.
  Cross-Functional Collaboration
• 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.
  Compliance & Audit Readiness
• 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.
• Documentation & Training
• 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.
  Continuous Improvement
• 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 and Experience

• 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.

• 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.

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 in New 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 Requirements
The 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 Carefully
Lupin 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

Competencies