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
