Senior Quality Specialist
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- 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
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.
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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
