Quality Assurance, Quality Systems Manager

Overview

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.

Responsibilities

Role Summary

The Senior QA-Quality Systems performs Quality Assurance tasks per Lupin Respiratory R&D’s Quality Assurance programs and procedures; develops and maintains Quality Systems and Controls that are appropriate and effective; Ensures that R&D functions and manufacturing operations are conducted in full compliance with the Current Good Manufacturing Practices (cGMPs), where required, and in accordance with internal procedures and other pertinent regulatory requirements; Ensures that all relevant employees are adequately trained on company procedures, policies and programs; Conducts internal and external quality audits to ensure compliance with regulatory requirements, company procedures and for continuous improvement; Ensures R&D associates follow sound scientific practice and approach

Essential Duties and Responsibilities

• Leads in the design and development of Lupin Research Inc., Quality Systems.
• Identifies areas of improvement within the Quality Systems and leads/manages required changes.
• Review and approve qualification and commissioning of facilities, instruments, equipment and software.
• Support QA in providing oversight to Product Development, R&D Operations and Manufacturing Operations Groups, including clinical trial material manufacture, laboratory analysis and release of products to clinic and for commercial distribution.
• Review and approve of cGMP documentation, including, but not limited to: specifications, standard operating procedures/ test methods, batch records, protocols, certificates of analysis, analytical reports, method validation/transfer reports, quality agreements and training files.
• Maintenance of electronic QMS for document, CAPA, Quality Event, Complaint, and Audit handling.
• Facilitate quality-related training and mentoring, where required.
• Review, approve and manage investigations, deviations, change management, incidents, complaints, out-of-specification results (OOS) and Corrective and Preventative Actions (CAPA).
• Perform internal and external audits against cGMPs and supports QA during 3rd party audits & regulatory agency inspections.
• Lead Evaluation and Qualification of Vendors and Suppliers.
• Trend quality metrics including investigations, deviations, incidents, OOS results, CAPAs, change management and audit follow-up. Present quality metrics to senior management in Quality Council meetings.
• Manage internal or external transfer of analytical methods and R&D projects to other Lupin sites.
• Perform other duties as assigned.

Qualifications

Education and Experience

• A Bachelor’s Degree (B.S.) in Chemistry, Biology, Microbiology or Pharmacy related field. A minimum of 10 years’ experience in an FDA-regulated or Pharmaceutical/Medical Device manufacturing environment. 
• A thorough knowledge of cGMP regulations as they apply to Drugs and Medical Devices is required. Experience with Respiratory Product development is preferred. Relevant experience with laboratory and manufacturing functions along with GMP quality assurance functions is required.
• Experience in laboratory practices, release of starting materials and products, conducting investigations, as well as, internal and external audits. Certification in auditing preferable.
• Experience in conducting audits against cGMPs and ISO 13485 guidelines for medical devices.
• Ability to work and make decisions independently and on multiple projects, flexibility to adapt to changing priorities. Ability to handle internal resistance and enforce adherence to internal quality policies and the cGMPs.
• Ability to interface and work with a diverse group of departments and individuals is required.
• Must be team oriented with excellent interpersonal skills. Must have the ability to express regulatory requirements clearly and understandably.
• Must possess excellent oral and written skills in the English language.

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.

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