Sr. Director Quality Systems & Strategy

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

Job Function

Quality

Job Sub Function

Quality Systems

Job Category

People Leader

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

• 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-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 are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

Bachelor’s degree in engineering, life sciences, biomedical engineering, or related technical field; advanced degree preferred.

12+ years of progressive quality systems experience in medical devices or related regulated field; minimum 5 years in senior leadership.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

Demonstrated experience developing and executing enterprise/platform-level quality strategy and leading organizational development for quality functions.

Deep familiarity with QMS standards and regulations: ISO 13485, FDA QSR/21 CFR Part 820, EU MDR, GMPs and other applicable international regulations or directives.

Proven record managing external regulatory or notified body inspections.

Strong cross-functional influence, communication and stakeholder management skills.

LOCATION & TRAVEL REQUIREMENTS

Up to 25% of travel to sites, suppliers, and regulatory meetings based on business needs

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Preferred Skills

• Agile Decision Making
• Collaboration
• Compliance Management
• Corrective and Preventive Action (CAPA)
• Data Quality
• Developing Others
• Incident Management
• Inclusive Leadership
• Leadership
• Operations Management
• Performance Measurement
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Services
• Quality Standards
• Risk Management
• Succession Planning
• System Integration
• Systems Analysis
• Tactical Planning

Salary

The anticipated base pay range for this position is :

$178,000.00 - $307,050.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits