Sr. Director Quality Systems & Strategy

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

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We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
People Leader

All Job Posting Locations:
Danvers, Massachusetts, United States of America

Job Description:

JOB SUMMARY

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.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:


* 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 MedTech 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-buildi...