Senior Quality Specialist

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:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, New Brunswick, New Jersey, United States of America

Job Description:

Position Summary

Senior Quality Specialist Change Control / Document Control is responsible for leading and supporting Global Compliance activities related to change control and document control processes. This role provides subject matter expertise (SME) to support the integration of new projects into enterprise systems and leads initiatives to enhance system capabilities and operational efficiency.

The position serves as a key liaison for system support and troubleshooting (e.g., EDMS/PLM), while collaborating cross-functionally to ensure all change control and documentation activities are accurate, timely, compliant, and audit-ready.

Key Responsibilities

• Oversee daily operations supporting Global Compliance Change Control / Document Control activities.
• Provide subject matter expertise for onboarding new projects into existing systems and lead system enhancement initiatives.
• Serve as a primary interface for troubleshooting and supporting electronic systems (e.g., EDMS/PLM).
• Analyze, monitor, and report on the effectiveness and efficiency of Change Control / Document Control metrics.
• Proactively evaluate systems, processes, and procedures to identify opportunities for improvement, standardization, or elimination of inefficiencies.
• Develop, author, and implement global programs, procedures, and standards for Change Control / Document Control.
• Lead and participate in technical reviews of change requests and document revisions, ensuring compliance with internal policies and applicable regulatory requirements.
• Review and approve document revisions and change control records for accuracy, completeness, and compliance.
• Operate independently to resolve complex issues while serving as a recognized SME within the functional area.
• Partner cross-functionally (Quality, Regulatory Affairs, R&D, and Operations) to ensure audit readiness and support inspection activities.
• Support environmental policies and departmental sustainability objectives.
• Perform additional duties as assigned by management.

Qualifications & Education

• Bachelor’s Degree or equivalent experience in a Quality Assurance (QA), Research & Development (R&D), or Regulatory Affairs (RA) environment.
• 7–10 years of relevant experience in QA, R&D, or RA within a regulated industry.
• Demonstrated experience with Change Control and/or Document Control processes in a global or highly regulated environment.
• Strong knowledge of electronic document management systems (EDMS) and compliance requirements (e.g., FDA, ISO, GMP).
• Proven ability to lead cross-functional initiatives and drive process improvements.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills, with the ability to influence stakeholders at all levels.
• Ability to work independently while managing multiple priorities in a dynamic environment.

Preferred Qualifications

• Experience supporting audits and regulatory inspections.
• Familiarity with global change control governance processes or Technical Review Boards (TRB/CCRB).
• Experience in medical devices, pharmaceuticals, or other highly regulated industries.
• Windchill PLM Experience

 

Required Skills:

 

 

Preferred Skills:

Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment

 

 

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

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