Director, Quality Programs-Integrated Supply Chain (ISC)

Your role:

• Leadership and Team Management: Lead, mentor, and manage a team of Program Managers and data analyst responsible for quality programs. Foster a collaborative and high-performance culture within the team. Provide guidance, support, and development opportunities to ensure team effectiveness and professional growth.
• Strategic Planning and Execution: Develop and implement strategic plans for quality programs, including Artificial Intelligence (AI), that align with organizational goals and regulatory requirements. Oversee the planning, execution, and completion of quality compliance projects to ensure they lead them in accordance with timelines, budgets, and objectives. Identify and address potential risks and issues that could impact project success.
• Product Quality, Quality Management System, Compliance and Standards: Ensure adherence to industry standards, regulatory requirements, and internal quality policies. Monitor and evaluate the effectiveness of quality programs, making adjustments as needed to maintain compliance and improve outcomes. Stay informed about industry trends and best practices to continuously enhance quality programs. Lead improvements in data and analytics by improvement current tools and practices
• Cross-Functional Collaboration: Collaborate with other departments, including Operations Quality, Operations, Engineering, Business, and Supply Chain, on programs and outcomes. Serve as the primary point of contact for quality-related inquiries and concerns from internal stakeholders.
• Reporting and Documentation: Prepare and present reports on project status, performance metrics, and compliance to senior management. Ensure accurate and timely documentation of quality program activities, including project plans, reports, and compliance records.
• Continuous Improvement: Drive a culture of continuous improvement by implementing best practices and innovative solutions to enhance quality and efficiency. Lead initiatives to identify opportunities for process improvements and implement corrective actions as needed

You're the right fit if:

• You have a minimum of 10+ years’ experience in FDA regulated medical device manufacturing/supply chain environments, providing strategic leadership for large scale, global, cross-functional quality programs/projects.
• You have a proven track record of successful program/project management, transformation, change management, continuous improvement and team leadership in a matrix environment
• You have proven experience in functional management of PMO/Quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
• You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
• You have proven expertise utilizing/improving data analytics- Quality KPI’s/Data Analysis to assess program/quality/team performance and identify process and continuous improvement opportunities.
• You’re able to effectively communicate, influence and build relationships with cross-functional team members at ALL levels.
• You have a minimum of a Bachelor’s degree in Quality, Engineering or a related Scientific discipline (required). Advanced degree or relevant certifications (e.g., Six Sigma, PMP) preferred.