Senior Director, Quality Systems (USA)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  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 Documentation

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Titusville, New Jersey, United States of America

Job Description:

Role Summary

The Senior Director, Quality Systems will provide enterprise leadership for the strategy, roadmap, operation, and sustainment of core QMS systems and enabling platforms. This leader will partner closely with Innovative Medicine Quality & Compliance, Enterprise Quality, IM Digital Quality, JJT, Global Process Owners, and regional stakeholders to ensure QMS systems support business priorities, regulatory expectations, inspection readiness, and continuous improvement.

The role will lead global QMS system strategy, business ownership, system investment planning, and operational services, including support for Transcend, QMS Operations, LMS, EDMS, and related QMS workflows. This leader will also provide strategic direction, people leadership, governance, and stakeholder engagement to advance a scalable, compliant, and digitally enabled QMS ecosystem.

Key Responsibilities

• Lead the global QMS systems strategy, investment roadmap, and governance model to support current and future Innovative Medicine Quality & Compliance priorities.

• Oversee planning, execution, sustainment, and continuous improvement of QMS system initiatives and investments.

• Serve as business owner for core QMS systems and enabling platforms, including LMS, EDMS, QMS workflows, and related operational capabilities.

• Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders to ensure systems are aligned with process needs, quality architecture, and enterprise priorities.

• Provide Quality leadership and guidance for strategic system investments, ensuring compliance with applicable GxP, computerized system validation, and quality requirements.

• Develop scalable operational services and support models that enable consistent, efficient, and compliant QMS operations.

• Represent IM Quality Systems in enterprise transformation efforts, governance forums, and senior leadership discussions.

• Lead, develop, and engage a global team, fostering accountability, collaboration, inclusion, and high performance.

• Monitor internal and external trends in Quality Systems and digital capability to identify opportunities for simplification, standardization, innovation, and value creation.

• Develop dashboards, metrics, and leadership updates to provide visibility into QMS system performance, investment progress, risks, and opportunities.

Qualifications

• Bachelor’s degree is required.

• Minimum of 12 years of relevant experience in Quality Systems, Quality Operations, digital quality, program management, transformation leadership, or a related regulated environment.

• Experience with Quality Management System platforms and solutions supporting GxP processes.

• Demonstrated experience shaping system roadmaps, leading system investments, and translating business needs into executable plans.

• Strong understanding of quality systems, regulatory expectations, computerized system validation, and continuous improvement principles.

• Proven ability to influence, collaborate, and drive alignment across senior leaders, global teams, and matrixed stakeholders.

• Strong strategic thinking, communication, presentation, analytical, and decision-making skills.

• Experience leading teams, developing talent, and creating an inclusive, high-performance team environment.

• Ability to manage multiple priorities and deliver high-quality outcomes in a complex, global organization.

​Preferred Qualifications

• Advanced degree such as M.S., MBA, Ph.D., Pharm.D., or equivalent is preferred.

• Experience in pharmaceuticals, healthcare, medical technology, or another highly regulated industry.

• Experience with QMS platforms such as Veeva, TrackWise, ComplianceWire, EDMS, LMS, or similar systems.

• Experience partnering with digital, technology, process ownership, and quality organizations to deliver enterprise-scale transformation.

• Experience developing metrics, dashboards, and executive-level updates to support decision-making and governance.

Travel

• This position may require up to 10% domestic and international travel 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  ([email protected]) or contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Business Alignment, Compliance Management, Compliance Policies, Developing Others, Inclusive Leadership, ISO 9001, Leadership, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Stakeholder Engagement, Standard Operating Procedure (SOP), Statistical Process Control (SPC), Systems Thinking, Technical Writing

 

 

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:
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