Global Quality Systems & Strategy Director

Biopharma Careers; Danvers (MA); On-site; USD 184,000 - 307,000; Full time

Benefits offered by this job

Vacation 120 hours

Sick time

Parental Leave

401(k)

Long-term incentive

Job summary

Johnson & Johnson in Danvers, MA is seeking a Sr. Director, Quality Systems to lead the design, implementation, and optimization of the QMS for the Heart Recovery platform and broader Quality & Compliance organization.

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.

Qualifications

• Bachelor’s degree in engineering, life sciences, biomedical engineering, or related technical field.
• 12+ years of progressive quality systems experience in medical devices or related regulated field; minimum 5 years in senior leadership.
• Deep familiarity with QMS standards and regulations: ISO 13485, FDA QSR/21 CFR Part 820, EU MDR.
• Proven record managing external regulatory or notified body inspections.
• Strong cross-functional influence, communication and stakeholder management skills.

Responsibilities

• 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).
• Oversee core QMS processes: Document control, CAPA, change control, Training and Escalation processes in alignment with applicable local and MedTech shared procedures.
• 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.
• 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.

Skills

Quality Strategy

Leadership

QMS

Regulatory Readiness

Cross-functional Influence

Audits

Process Improvement

Education

Bachelor’s degree in engineering, life sciences, biomedical engineering, or related technical field

Advanced degree preferred

Job description

Johnson & Johnson in Danvers, MA is seeking a Sr. Director, Quality Systems to lead the design, implementation, and optimization of the QMS for the Heart Recovery platform and broader Quality & Compliance organization.

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.