Alvogen Pine Brook, Inc. seeks a qualified Sr. Project Mngr. @ its Pine Brook, NJ facility. The Sr. Project Mngr. will lead cross functional project teams including internal 3rd third-party representatives to drive development, validation & launch for U.S. Generics and Brand injectable, transdermal, inhalation, topical, & oral solids portfolio.

The QA Manager, Technical Services is a member of the US Quality department. In interacting primarily with Alvogen’s external business partners / CMOs, exercising Quality Management Systems and GMP Compliance oversight of them, the Manager is responsible for supporting the administration and implementation of Alvogen’s Quality Management Systems and adhering to all associated documentation requirements for the Alvogen Inc. and the Almatica Pharma Inc. business units.

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.