Quality/Compliance Analyst

Job Overview

This roleisresponsible forexecuting and supporting regional operations in the areas of Document Management, Quality, Compliance, and SOX Reporting and for providing superior advisory and analytical support to internal and external customers enabling the compliant execution of critical customer focused operations. 

Key Responsibilities:

Day-to-Day Activities: 70%

• Support and continually work within the parametersestablishedby a risk-based Quality Management System framework. 

• Serve as theCustomer Service (CS)Subject Matter Expert (SME)regardingSOX financial reporting, Quality and Compliance.  

• Benchmark internally and externally,regionallyand globally, to gather, share, and implement standard methodologies accordingly. 

• Assist CS Senior Leaders with development and implementation of organizational and strategic plans designed to improve efficiency of department processes, using technology and other platforms to standardize, leverage and/oreliminatemanual interactions wherever possible.

• Lead and manage projects related to broader Supply Chain initiatives, as. 

• Your Key Performance Indicators for this role include on-time completion/compliance with SOX reporting. 

• Support change management strategies by applying change management principles and tools 

• Support the development and maintenance of internal resources to provideaccurateSOX financial, Quality and Compliance information.

Day-to-Day Activities: 10%

• Provide CS Quality & Complianceexpertiseon applicable projects.

• Lead and/or support key departmental/cross-functional/cross-sector projects, as assigned, by developing andutilizingin-depth knowledge of business processes and systems, as well as project management skills. 

• Use continuous improvement tools andmethodology, including Process Excellence, LEAN, and project management, toidentify, evaluate, challenge, develop solutions, andoptimizebusiness processes that drive measurable improvement.

• Regularly communicate in all directions to keep associates, peers, and Management informed of project status, process changes, and opportunities. 

• Drives / supports regional and global CS projects for the US region using FPXmethodology,toolsand best practices. Conducts lessons learned post-implementation andidentifiesopportunities to continuously improve.

Day-to-Day Activities: 10%

• Support documentation management, Quality, and Job Function Curriculum (JFC).

• Support with managing departmental/Regional Change Control documentation and deliverables to ensure the on-time completion. 

• Support with the on-time completion of Annual Training Record Review (ATRR) and lead on-time completion of controlled document periodic review.

• Support with Key Performance Indicators for On-Time Periodic Review.

• Support with development, implementation, and evaluation ofmetrics with meaningful insights for customer service in the areas of Document Management.

Day-to-Day Activities: 10%

• Complete required compliance/assigned training by required due date.

• Allduties asassigned by manager and/or supervisor.

Qualifications

Education

• Required:Bachelor’s degree in Quality, Engineering, Supply Chain, Life Sciences, Business, ora relatedfield.

• Preferred: Coursework or concentration in Quality Management, Regulatory Affairs, or Operations.

Experience and Skills

Required:

• 2 to 4yearswork experience in relevant Quality, Compliance, or Supply Chain position within a regulated, fast-paced business environment

• Work experience in Quality, Compliance, Document Management/Control, Technical Writing, or Supply Chain

• Ability to analyze basic data andidentifytrends to support continuous improvement.

• Proficiencywith standard office and data tools (e.g.,Microsoft Office).

• Demonstrated time management skills with consistenttrack recordto handle multiple competing priorities/deadlines, ability to act with a sense of urgency, and deliver expected/exceeding results

Preferred:

• Experience in a medical device, pharmaceutical, or other regulated industry.

• Exposure to audits, CAPA, change management, or supplier quality activities.

• Familiarity with Lean, Six Sigma, or continuous improvement methodologies.

• Experience supporting global ormulti‑siteoperations.

• Ability to work effectively incross‑functionalteams.

• Effective written and verbal communication skills.

• Strong attention to detail and ability to manage documentation accurately.

Other:

• Language: English (required).

• Travel:Limited; upto 10% domestic and/or international, as needed.

• Certifications:Quality‑relatedcertifications (e.g., ASQ) preferred, not.

For more information on how we support the whole health of our employees throughout their wellness,careerand life journey, please visitwww.careers.jnj.com.