Senior Quality Specialist

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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…