Manager, QMS Quality Issue Management Lead


Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for a Manager, QMS Quality Issue Management Lead to be based in Raritan, NJ but can also be located in Titusville, NJ, Springhouse, PA, Malvern, PA or field based with remote capabilities.


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.


We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.


The Manager, QMS Quality Issue Management Lead, will support the creation, monitoring, effectiveness and closure of self-identified Quality Issues and CAPA across R&D (e.g. Therapeutic Areas (TA), Global Clinical Development Organization (GCDO), Bioresearch Quality &Compliance (BRQC) Janssen etc.).


In this role, you will be responsible to assist and support the development and management of oversight strategies and programs related to self-identified CAPAs to ensure that quality issues and events identified are robustly investigated, corrected and documented in the Janssen CAPA management system as well as escalated to senior management when appropriate.


Main responsibilities will include, but are not limited to:

  • Collaborate with key stakeholders to support the development and implementation of a process for self-identified management of quality issues and action plans identified
  • Assess quality issues identified by R&D Business Partners and BRQC Janssen colleagues to determine if further investigation (including root cause analysis if applicable) is needed
  • Collaborate with functional owners of investigations to ensure robust investigations (with root cause analyses if applicable) are conducted and documented
  • Review and approve corrective action and effectiveness check plans as well as documentation of completion of approved commitments in the CAPA management system
  • Complete records (including coordination of evidence) to document the outcome of investigations in the CAPA management system
  • Monitor the effectiveness of implemented corrective action plans to ensure they address the root causes identified during the investigations
  • Develop and present periodic updates on key performance indicators related to the status of on-time delivery of self-identified CAPA commitments and the overall effectiveness of the actions implemented
  • Serve as a champion to key R&D Business Partners to liaise between quality groups and governance bodies to enable and promote quality, accountability and quality culture
  • Escalate individual CAPAs at risk and/or negative trends in Key Performance Indicators to the appropriate forums and management
  • Engage with key operational and quality stakeholders to drive investigation and development of action plans to address any quality issue trends identified by the BRQC Janssen Quality Management Systems team
  • Provide meaningful interpretation of trends and signals identified
  • Support BRQC/Janssen CAPA and Quality Leader forums or equivalent to ensure oversight of CAPA measures

Qualifications
  • A minimum of a Bachelor of Science (BSc) or equivalent degree is required.
  • A minimum of 8 years of experience in a medium to large scale matrix organization or equivalent time.
  • A minimum of 8 years of previous Pharmaceutical Industry experience is required.
  • A minimum of 5 years’ experience in an applicable compliance field and/or the equivalent time and training/experience in a related R&D area (GxP regulated discipline) is required.
  • Knowledge of the global drug development process, including current functional GxP compliance regulations is required.
  • Strong analytical skills & experience with implementation of new concepts is highly preferred.
  • Must be a problem solver, proactive strategic thinker, strong leader and collaborator
  • Strong written, visual, verbal communications with peers, business partners & senior management
  • Ability to analyze and interpret data, derive insights, and determine root cause to adjudicate issues in the research and development process
  • Ability to drive change management within a matrix organization and with business partners
  • Experience working with multidisciplinary and cross functional leaders from R&D, Medical Safety, Regulatory and Quality functions
  • Experience using TrackWise application is required.
  • This position may require up to domestic and international travel as business demands.

Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.


Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States, North America-United States-Pennsylvania-Spring House, North America-United States-Florida-Titusville, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
5841180704