The Manager of Site Compliance is responsible for the Quality Systems within Lupin Somerset related to Internal Audits, Vendor Qualification and routine Annual Product Reviews. The Manager must have sufficient experience in evaluating pharmaceutical manufacturing practices and understand industry standards to appropriately evaluate practices and procedures and be very familiar with various types of manufacturing technologies and associated Quality Systems. The experience should include specific technologies such as wet granulation, fluid bed coating, high speed compression, encapsulation, tablet coating, and liquid filling. The qualified candidate has appropriate experience in dealing with Governmental officials within the FDA. Additional areas of responsibility include evaluating staffing needs, establishing requirements as per GMP and European standards, budget, training, prioritizing and scheduling of team activities and reporting quality progress on a monthly basis to site management. This position must assure all GMP systems are of the highest quality and meet all applicable standards.
Responsible for implementing and maintaining a compliant Vendor Audit program per FDA and Lupin Limited requirements
Maintain a system for annual Compliance Audits within the Lupin Somerset sites.
Establish robust Quality Agreements with all 3rd party manufacturers, contract laboratories and suppliers.
Manage the site Compliance committee to track, evaluate and report compliance risks
Promote organization’s growth and adherence to industry standards
Ensures all company procedures, policies and systems are in accordance to industry regulations.
Direct the development and implementation of departmental goals and objectives.
Reporting on the performance of the quality system to corporate representatives and internal management.
Coordinates, prepares, participates & responds to FDA, Foreign regulatory agencies and third party inspections.
6+ years’ experience in a Quality and/or Regulatory management position in pharmaceutical manufacturing, preferably with some experience in aseptic processing.
Working knowledge of FDA and applicable non-US regulations pertaining to pharmaceutical drug manufacturing
Excellent managerial skills; includes project management, problem-solving, written and verbal communications, and organizational abilities
Excellent teamwork, leadership, influencing, and coordinative skills; must be able to work with diverse teams to achieve results
The ability to train employees, develop junior managers, and raise process improvement skills and overall quality standards across multiple functions
Lupin Somerset is an operating division of Lupin, which is among the top performing global generic pharmaceutical companies. Lupin Somerset is located in central New Jersey and is the first manufacturing facility in the United States for Lupin. There are approximately 400 employees in the Somerset, New Jersey division working in all functional areas including Research & Development, Manufacturing..., Packaging, Warehouse, Finance and Accounting, Human Resources, Regulatory Affairs, Information Technology, Quality Control, Compliance, and Quality Assurance.