Job Description

The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our West Point campus, internal manufacturing facilities, external contract manufacturers and suppliers we create a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and Patients on time, every time, across the globe.

The Quality Engineering Director will be a core member of the West Point Quality Leadership Team (QLT) and serves as a quality leader accountable for the quality oversight of maintenance, equipment reliability, validation and engineering organizations including service providers supporting the West Point Manufacturing and Quality Control laboratories. The scope of the role will include maintenance and validation oversight for Manufacturing facilities and QC labs. Additionally the role will also oversee capital projects and new facility establishment. This position will report directly to the West Point Site Quality Head (SQH). The Engineering and Maintenance group is responsible for improving asset reliability and manufacturing capacity by providing technical support in the field on engineering resolution of manufacturing mechanical or automation problems, and maintaining processes in compliance with GMP, safety, and environmental regulations. The incumbent will lead establishment of the organizational model for Quality Engineering and will be responsible for development of the key responsibilities, performance indicators, actions to achieve a sustainable organization design across the West Point site. The responsibilities of this role will additionally include sustainment through continuous improvement of the organization at the site.

• Establish and lead the Quality Engineering Department at the West Point site.
• System owner for the Facilities, Utilities, Equipment and Manufacturing Controls QMS topic for the site.
• Point person for coordination and deployment of quality oversight procedures and expectations for the organization (e.g. routine maintenance and capital projects)
• Ensuring that the Governing procedures are robust and aligned to QMS and Global Procedures and the procedures enable the organization to be successful.
• Coach, teach, connect applicability and importance of quality systems/GMPs
• Management and support for Quality capital planning/management.• Responsible for inspection readiness and regulatory inspection support across West Point Engineering and Maintainance scope
• Ensure that short term and long-term team objectives are established for the newly established organization and achieved while reliably supplying quality product.
• Provide tactical and strategic direction to the Engineering Quality team including leadership influence within the cross functional team of support.
• Promote the behaviors and principles that drive continuous improvement
• Develop and continue to drive improvement to key performance indicators and business outcomes within the newly established Quality Engineering organization.
• Financial Stewardship - Responsible for development and management of the Quality Engineering team operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing cost. Ensure members of the team have high business acumen and understand how they may impact business finances.
• People Management - Responsible for creating, hiring and sustaining a highly engaged workforce through utilization of Enterprise Leadership Behaviors and Inclusion. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Team with other members of the QLT team and/or Site Leadership team to plan and implement talent management plans for the Quality Engineering staff.
• Leads efforts to monitor and establish processes and systems to ensure compliance with regulatory requirements (e.g. FDA, EMA, ICH)
• Stays current on emerging trends, technologies and regulatory developments.

• Bachelor's degree (BA/BS with fifteen years applied professional work experience in one of the following pharmaceutical work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT. OR
• Master's degree (MA/MS) with ten years applied professional work experience in one of the following pharmaceutical work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.

• Applicable experience, strong understanding and knowledge of relevant quality systems expectations in the biotechnology or vaccine industry.
• Proven success in delivering strategic projects and organizational design/ establishment.
• In-depth knowledge of regulatory requirements and guidelines (e.g. 21 CFR part 11, Annex 11)
• Strong working knowledge of Engineering, Maintenance, Manufacturing support systems, and associated business processes.
• Excellent communication, leadership, and problem-solving skills
• Very skilled at organizing complex topics, strong project management skills, able to handle multiple tasks concurrently
• Adapts to rapidly changing business needs
• Fosters positive, transparent and productive relationships
• Proven history of challenging the status quo of business standards and processes with the ability to propose solutions
• Proven history of developing strategic plans and implementing on time
• Ability to be decisive and influence management with demonstrated leadership skills and management of large teams.
• Experience in managing cross-functional initiatives or programs
• Understanding and experience in various business methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)

• Experience in a Quality organization (quality systems) and/or Manufacturing operations (Automation) preferred
• Incumbent with facilities and engineering support experience are preferred.