Sr. Director Quality Systems & Strategy

Job Function

Quality

Quality Systems

People Leader

Danvers, Massachusetts, United States of America

The Sr. Director, Quality Systems will lead the design, implementation, and continuous optimization of the Quality Management System (QMS) for the Heart Recovery platform and own strategy and capability development for the broader Quality & Compliance organization supporting the platform. This role ensures product quality, regulatory readiness, operational excellence, and a high-performing, scalable quality organization across development, manufacturing, and post-market activities for cardiac therapies and devices.

This role is appointed the Management Representative and is responsible for ensuring that quality system requirements are effectively established and maintained.

• Define, maintain and scale the platform QMS strategy aligned with corporate objectives and applicable regulations (e.g., FDA QSR/21 CFR Part 820, ISO 13485, EU MDR and other applicable international regulations or directives).
• Oversee core QMS processes:
  Document control, CAPA, change control, Training and Escalation processes in alignment with applicable local and Med Tech shared procedures, where applicable.
• Provides advisory support to QMS elements associated to Design and Product Lifecycle Management as required.
• Ensure there is a comprehensive Inspection Readiness plan in collaboration with J&J Regulatory Compliance.
• Develop and lead the multi-year quality strategy and roadmap for the Heart Recovery platform, aligning with business milestones (clinical, scale-up, commercialization).
• Build and operationalize sustainable organization plan for the Quality Systems team: structure, roles, and skills roadmap.
• Own workforce planning, budgetary planning, and prioritization for quality investments (tools, training, external audits).
• Lead capability-building initiatives (training programs, competency frameworks, leadership development) to raise Quality Systems and compliance maturity across platform end to end execution.
• Drive harmonization and standardization of policies, procedures, and metrics across geographies and business units supporting the platform.
• Define and govern quality KPIs and governance cadence for the Quality & Compliance organization, present status and strategic recommendations to senior leadership and governing boards.
• Identify and lead strategic initiatives to drive operational excellence & continuous improvement of the Quality Management System.
• Implement and optimize digital quality tools and data-driven dashboards.
• Ensure on time execution of Internal and External audit corrective and preventive actions.
• Drive continuous improvement projects to reduce risk, improve cycle times (CAPA, change control), and enable scale-up.
• Cross-functional partnership & advisory for Quality Management System related opportunities.
• Translate enterprise-level quality policies into pragmatic, risk-based procedures that enable product development and commercialization.
• Recruit, coach, and develop a high-performing, Quality & Compliance organization; set performance expectations and career development plans.
• Champion a culture of Quality and Accountability emphasizing patient safety, product integrity, and ethical compliance.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so…