The Director, Quality ensures quality and compliance of Sterile/Combination Products and Medical Devices. In this position, the Director develops strategic direction and provides the governance/oversight of this segment of products operations that comprise the company portfolio. The Director leads the team that directly interacts with company’s external business partners/CMOs and has responsibility for oversight of multiple complex sterile products including combination products throughout the entire lifecycle of the product (i.e. from development through final decommissioning and disposal) and is responsible for supporting the adherence to company’s Quality Management System.The position will require a strong first-hand knowledge of the regulations and international standards governing Combination Products distributed in multiple commercial markets within the US, EU and ROW i.e., QSRs, ISO 13485 and MDRs.RESPONSIBILITIES

Provides guidance and supervision to a team of Quality Managers who work with Contract Manufacturers and partners which manufacture and/or supply injectable/combination products for company.Ensures all injectable/combination products manufactured for or on behalf of company by third party suppliers are manufactured, packaged, and tested in compliance with cGMPs, the approved ANDA/NDA, applicable regulatory requirements, and company policies and procedures.Manages the batch release process for all third party manufactured injectable/combination products.Ensures company Quality review and approval of all vendor generated batch documentation, including but not limited to process validation protocols and reports, analytical method validation protocols and reports, methods, specifications, labeling documents, master and executed batch manufacturing and packaging records, deviations, investigations, change controls, and corrective and preventive actions.Ensures that regulatory requirements including but not limited to Annual Product Reviews, stability management, reserve/retain sample management are in compliance for the injectable/combination product portfolio.Implements, maintains and ensures adherence to the Company QMS.Ensures Sterile/combination product group’s adherence to Metrics Reporting & TPQ’s ‘Quality Management Review’ Activities.Oversees Sterile/combination product group’s Performance Mapping / CMO Evaluation Reporting.Partners with Supply Chain and represents US TPQ in the Sales Inventory and Operations Planning process.Partners with R&D, the Product Launch Team, etc. to support the development and launch of US products from CMO’s and internal company sites.QUALIFICATIONS

BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 15 years’ experience in the Pharmaceutical Industry preferred, with a minimum of 10 years in an ISO 13485 certified organization. Other degrees will be considered based on extensive industry experience.Minimum of 15 years' experience should also include at least 5 years' experience as a manager across multiple departments/functions of the Quality organization (e.g. QA, QC, etc.).Extensive Quality experience with injectable/combination products is required.Approximately 25-30% business travel required to external Contract Manufacturing Organization (CMO) / Business Partner sites, to attend professional development training seminars.Seniority level

DirectorEmployment type

Full-timeJob function

Quality Assurance, Manufacturing, and ScienceIndustries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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