Director, Quality Engineering

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 West Point Quality organization is a team of leaders who will exemplify and cultivate the Company's core leadership behaviors and ways of working, fostering a culture of collaboration, innovation, and accountability across all levels of the organization while maintaining alignment with the company's values and strategic vision.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Engineering Director 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 Director is responsible for implementing Divisional, Company and Site policy, procedures and guidelines and for discharging Quality Operations responsibilities.  These activities include a broad involvement in all Quality aspects associated with the activities, including deviation management, change control, and compliance.  They act as key regulatory compliance liaison to interface with regulatory agencies during inspections.  They are a member of the Site Quality Leadership Team and Equipment, Maintenance and Utilities Senior Leadership Team and direct Quality activities associated with the various teams.

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 include sustainment through continuous improvement of the organization at the site.

Primary Activities:

• 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.  Maintains Quality Management systems and drives sustained compliance.
• 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 Quality Management System and Global Procedures and the procedures enable the organization to be successful.
• Contributes to the process for updating policies and guidelines for the West Point site and our Manufacturing Division.
• Actively ensures multi-disciplinary teams work efficiently to drive to thorough root cause analysis and effective and timely closure of investigations. Drives efforts to reduce deviations.
• Ensures that personnel operate within established policies/procedures of the Division and Corporation and comply with all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign.
• Coach, teach, connect applicability and importance of quality systems/GMPs
• Proactively partners with cross-functional groups to ensure projects are timely and robust providing quality, technical and scientific support to ensure corporate goals.
• Management and support for Quality capital planning/management.
• Responsible for inspection readiness and regulatory inspection support across West Point Engineering and Maintenance scope
• Ensure that short term and long-term team objectives are established for the Quality Engineering organization and achieved while reliably supplying quality product.
• Provide tactical and strategic direction to the Quality Engineering 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 Quality Engineering or