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 twelve 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.

Role and Responsibilities

The Manager QA, Audits and Compliance is responsible for establishing and implementing a robust vendor qualification program, which includes performance of on-site and remote / desktop vendor audits in compliance with FDA regulations, guidance, and other recognized industry standards.  The position is also responsible for conducting internal audits in compliance with Corporate and Site procedures and escalating issues to site leadership for remediation.

Responsibilities and Duties:

• Establish and implement policies and procedures about Vendor Qualification Program at Lupin Somerset
• Conduct Internal and External audits to identify non-compliances and identify potential risks to materials/products and services as a result of observed non-compliances.
• Prepare and issue audit reports to communicate risks / non-compliances to respective department heads or vendors; collaborate with them for prompt resolution of identified issues.

• Support onsite and remote customer / regulatory audits. Assist with completing customer / regulatory commitments through the implementation of appropriate CAPAs
• Propose, review, and/or implement appropriate corrective actions and preventive actions (CAPA) based on the observations.
• Liaise with floor management and SMEs to identify additional procedural controls for overall improvement of compliance.

• Perform Risk Analysis for the products/materials in collaboration with SMEs. Escalate risks/issues to site leadership where necessary.
• Verify the CAPA effectiveness periodically and modify the CAPA accordingly.

• Other duties as assigned by leadership

Minimum Education and Experience Requirements

• Minimum Bachelor's Degree in a scientific or technical field; graduate degree desired
• 5+ years’ of extensive experience in the pharmaceutical industry in Quality Assurance. Cross-functional experience in Manufacturing, Packaging, Engineering, Technical Operations, Laboratory or Product development is a plus
• Working knowledge of FDA and applicable non-US regulations, guidance and industry standards about pharmaceutical drug manufacturing and auditing
• Experience with internal/external auditing and hosting customer / regulatory audits is required. ASQ-CQA certification desired
• Excellent verbal and written communication skills
• Experience in using electronic Quality Management System, ERP system, MS Office applications
• Excellent analytical, coordination and influential skills; Must be able to persuade vendors and cross-functional teams to achieve resolution of issues.

Work Schedule
The regularly scheduled workweek is Monday through Friday, and the hours are generally 8:00 am – 5:00 pm

Domestic / International Travel of up to 25%

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 10 pounds occasionally. Generally, work is performed in an office environment