Director Quality-Steriles

Summary Of Position

The Director, Quality- Steriles ensures quality and compliance of Sterile/Combo 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 Alvogen portfolio. The Director leads the team that directly interacts with Alvogen’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 Alvogen’s Quality Management System. This individual is a critical link between Alvogen’s external partners and the internal Alvogen team (e.g. Operations, Supply Chain, Business Development, R&D, Product Launch, Regulatory Affairs, Global / Corporate Quality, etc.). The individual will also be responsible for supporting Alvogen’s Corporate Quality Group with Quality Management Systems improvements / enhancements. 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. Being able to effectively communicate and transmit information to/from the partners is essential to ensure compliance and optimal performance. Be able to effectively multi-task in a fast-paced environment while demonstrating strong collaborative skills with Alvogen’s internal and external customers.

ORGANIZATION STRUCTURE

The Director Quality – Steriles is part of the Third Party Quality department. The position has Quality oversight of Alvogen’s Commercial and new Injectable/Combination products portfolio, specifically managing the team of Quality Associates, Sr. Associates and Managers working with Contract Manufacturers and partners which manufacture and/or supply injectable/combination products for Alvogen.

The Director, Quality – Steriles reports to the Sr. Director of Third-Party Quality and is based in Morristown, NJ.

Responsibilities

Primary responsibilities of this role include the following:

• Leadership: 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 Alvogen.
• Third-Party Support:
• Ensures all injectable/combination products manufactured for or on behalf of Alvogen by third party suppliers are manufactured, packaged, and tested in compliance with cGMPs, the approved ANDA/NDA, applicable regulatory requirements, and Alvogen policies and procedures.
• Manages the batch release process for all third party manufactured injectable/combination products.
• Ensures Alvogen 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.
• Ensure 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.
• Ensures that Quality Agreements are maintained with all suppliers, as required, including contract manufacturers, contract packagers, contract testing laboratories, API suppliers, etc.
• Support and/or perform GMP audits of third-party suppliers, as required.
• Compliance:
• Implements, maintains and ensures adherence to the Alvogen QMS
• Assures all third-party partners are in compliance with all appropriate regulations
• Assures that all third-party partner sterile/combination products meet requirements
• 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
• Interdepartmental Support:
• Partners with Supply Chain and represent 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 Alvogen sites
• Due Diligence – Is the main Quality point of contact for Due Diligence activities during the acquisition of new sterile/combination products and/or facilities. Must have Solid knowledge of cGXP and experience performing audits
  
  

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. This 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.
• Position requires expert knowledge of cGMPs, and strong understanding of FDA, USP, ISO and ICH guidelines. Knowledge of EudraLex and Part 4 a plus.
• Position requires excellent leadership skills in all areas of communication, influencing, collaboration, and decision-making.
  
  

Physical Demand Factors

• While performing the duties of this job, the Director Quality Steriles is required to sit and work at a computer for extended periods of time.
• Is regularly required to talk, listen, and attend meetings / teleconference calls.
• Approximately 25-30% business travel required to external Contract Manufacturing Organization (CMO) / Business Partner sites, to attend professional development training seminars, or otherwise as directed by the Sr. Director of Third-Party QA.
  
  

GMP DECISION-MAKING AUTHORITY

The position has the GMP decision making authority regarding the disposition of batches. Through the Quality team, and as required, approves all standards, specifications, master batch records, procedures, validation protocols and reports, change controls, batch records, deviations and release of acceptable products.

“An Equal Opportunity Employer, including disability/vets.”