The Director Combination Product Quality will ensure Alvogen’s medical device and combination product development and post-market processes and procedures are sustainability compliant. The role is responsible for setting strategies, driving implementation, and actively managing related change and communications.

The role of Manager, Procurement is to partner with the business to ensure efficient acquisition of goods and services that enables the commercialization and distribution of our products.  The role will need to interact effectively with senior leaders to ensure alignment with and delivery of business objectives, and ensuring that all sourcing strategies are compliant and follow company sourcing process.

The Associate Director of Pipeline Forecasting will assist and/or lead projects in support of Alvogen’s business development initiatives, specifically developing forecasts and supply plans for pipeline evaluations.

The Senior Director, External R&D is responsible to provide strategic R&D direction with a special focus on Third Party generic R&D projects, 505b(2) projects, tech transfer and R&D Due Diligence.  This is a key role with a wide responsibility to assist in portfolio selection, due diligence activities, oversee external development, and serve on project teams. Focus of this role is on both Solid oral  and non-Solid dosage forms such as injectables, inhalation products, transdermal products, topical products etc.  

The Associate Director, Supply Chain is responsible for implementing supply chain strategy and commercialization of new molecules, as defined by the business.  The position is accountable for launch excellence; supply continuity; product source changes; building trust and strong relationships with our third party manufacturers; integration of new CMOs/enterprises into Alvogen’s external/internal network; and for ensuring that supply chain due diligence is performed on potential M&A targets.

he Senior Associate, Quality Systems and Compliance provides Quality and Compliance support for all Quality Management Systems (QMS) and Compliance programs utilized by the Alvogen US groups based in the Morristown and Pine Brook, New Jersey locations and well as provide support to Regional Quality and Compliance initiatives impacting the NJ locations. He/she ensures the QMS and Compliance programs, associated policies and standard operating procedures are generated, implemented and maintained in line with regulatory and GxP requirements.

The Quality Manager is a member of the US Quality department. In this position, the QA Manager will have oversight and hands on management of: release testing and stability programs for complex sterile products – US and ROW. Tracking all testing, results for release, investigating shipping temperature excursions, manage and approve protocols for new stability programs, monitor ongoing stability programs, laboratory OOS/deviations, and managing change controls ensuring adherence to regulatory applications and Alvogen’s Quality Management System. Batch record review and batch release of product

The QA Manager Operations, 3rd Party reports to the Senior QRM, Operations of 3rd Party U. S. Quality. This position supports Alvogen’s commercial business, and works closely with Supply Chain, Project Management, Regulatory Affairs, Sales and Marketing, and external suppliers and partners. The position has no direct reports, and works along other Managers, 3rd Party Quality, QA Associates, and Sr.QA Associates

Independently authors, compiles, reviews and submits high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files.

This position is responsible for helping to plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements. Serves system administrator for Alvogen’s US Regulatory electronic document management system. He/she will serve as the primary publisher of US Regulatory submissions.