Johnson & Johnson Careers

Senior Compliance Associate, CAR-T Support

Spring House, Pennsylvania

Job Description

Requisition ID: 3545180215

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Senior Compliance Associate, located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit for more information.  
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The role of Sr. Compliance Associate will support compliance activities related to the clinical production of CAR-T cell therapy facility including supporting development, in-process testing, release and stability activities within PDMS in US.  The position will support implementation of quality systems and drafting SOPs including ensuring non-conformances are investigated thoroughly and approved in a timely manner, and appropriate corrective and preventive action plans are implemented in compliance with applicable regulations and guidance. The position will be accountable for establishing training program in accordance with quality systems. The associate will be instrumental in establishing development and validation processes for production facility, development, and release laboratories. In addition, the associate will assist in inspection readiness including providing support during internal audits and regulatory inspections. This position will interact with quality organization to promote compliance and proactively identify areas of improvements to reduce non-conformances and optimize processes.  Additional responsibilities include:
  • Drafts validation documents including production SOPs, calibration and maintenance procedures, process validations, analytical methods, protocols, study reports, and transfer reports.
  • Ensures non-conformances are thoroughly investigated and appropriate corrective and preventive actions are implemented per established procedures and regulations; Ensures timely closure of CAPAs and non-conformances, including effectiveness of corrective measures.
  • Ensure updates to facilities and processes are performed under approved change controls; Perform change control assessments.
  • Analyzes compliance issues and trends and maintains relevant metrics to improve quality systems and overall compliance.
  • SME support for all compliance related issues and in collaboration with quality team.
  • Participates in cross-functional team to ensure compliance measures are effectively implemented
  • Supports internal and external audits/site inspections for GMP regulated activities.
  • Develops and maintain local procedural documents in accordance with company and site policies and established regulations
  • Maintain processes and controls ensuring that performance and quality conform to established standards
  • Assist in implementation of new policies, manufacturing process, standards and guidance for new technologies; Ensure activities have been conducted per established procedures and regulatory requirements.
  • Provide input to ensure strategic compliance and quality requirements are met during manufacturing, development, tech transfer, and validation.
  • Implement procedures to ensure data integrity is preserved end to end per risk assessment.
  • Assist in preparation for internal and external inspections and audit, including compiling pre-requests.
  • Assist in audit response process including accountable for ownership of QEM quality actions for remediation.
  • Participate in quality investigations to evaluate conformance to specifications, company procedures, and overall compliance to regulations.
  • Inform/discuss with Compliance Lead potential risks and issues and/or opportunities for improvement and best practices to promote strong compliance.
  • Monitor compliance metrics, trend audit findings and compliance issues.
  • Liaisons with quality organizations and other functions to harmonize policies, practices, and procedures to increase quality and compliance and foster increased awareness of compliance.
  • Perform tasks in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA; Complies with all company and site policies and procedures.
  • Successfully completes regulatory and job training requirements; Makes a positive contribution to the organization, seeks opportunities for improvement

  • Bachelor’s degree in biology, immunology or other relevant scientific field with at least 5 years of regulated industry experience OR a Master’s degree in biology, immunology or other relevant scientific field with at least 3 years of regulated industry experience is required
  • At least 2 years of GMP experience within clinical/commercial research and development and/or quality assurance is required
  • Knowledge of the overall CAR-T drug development/manufacturing process is preferred
  • Knowledge and application of sterile processing is required
  • Experience in Quality Assurance, Quality Systems, and/or New Product Development in a regulated environment is required
  • Experience with writing SOPs, protocols, reports is required
  • Experience in clinical release and stability, technical transfer, process development, and process validation is preferred
  • Knowledge of current U.S. and EU cGMP’s/regulatory requirements is preferred
  • Knowledge of Good Tissue Practices, including sterile processing facility is preferred
  • Manufacturing equipment validation experience is preferred
  • Experience in quality assurance activities, including audits of systems and vendors is preferred
  • This role may require occasional overtime, work outside of core business hours or weekend work and up to 25% travel

Primary Location
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Job Function
Requisition ID