Johnson & Johnson Careers

Manager, Quality Management Systems Oversight

Raritan, New Jersey; Titusville, New Jersey; Horsham, Pennsylvania; Spring House, Pennsylvania; Beerse, Belgium; High Wycombe, United Kingdom
R&D


Job Description

Requisition ID: 00001C5U

Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for an Manager, Quality Management Systems Oversight located in Raritan, NJ; Titusville, NJ; Springhouse, PA; Horsham, PA; High Wycombe, England or Beerse, Belgium. 
 
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, Quality Management Systems Oversight will:
 
Main responsibilities will include but not limited to:
  • Liaise with key business partners to develop alignment and collaboration in GxP CAPA process oversight.
  • Manage an independent escalation method to support global GxP CAPA governance, and support the escalation of individual CAPAs at risk and/or negative trends in Key Performance Indicators.
  • Support interactions with key senior leaders to maintain executive awareness of GxP CAPA performance.
  • Plan, execute and deliver CAPA strategies/plans for the remediation, correction and prevention of recurrence of those significant quality events with broader impact across the Janssen R&D QMS.
  • Support investigation of large scale significant quality events, including the identification of issues, impact assessment, root cause analysis, oversight of appropriate communication and escalation to senior leadership, as appropriate.
  • Manage defined thresholds enabling the tracking/trending of escalated issues across the QMS holistically inclusive of CAPA escalations to leadership councils or forums.
  • Develop CAPA centralized tools and process training.
  • Support CAPA trending capabilities, enabling the identification of systemic root causes leading to the implementation of solutions to eliminate root causes.
  • Establish accurate and actionable metrics to identify areas of risk, performance to commitments, effectiveness and timeliness of GxP CAPAs.
  • Support Regulatory Inspection readiness initiatives and activities across GxP disciplines/segments, as appropriate.
  • Manage CAPA system/process to eliminate the causes of detected discrepancies (reactive), and preventive actions are in place to eliminate the causes of potential discrepancies of other undesirable situations (proactive).
  • Collaborate with five other functions (Quality Planning & Strategy, Quality Analytics, Quality Management, Quality Assurance, and Janssen Diagnostics Quality) and other quality groups through governance to support identification of risks within quality and compliance and implement appropriate mitigation actions across the R&D QMS.
  • Support BRQC/Janssen CAPA forums or equivalent to ensure oversight of CAPA measures.
  • Initiate notification and/or escalation of emerging and signification risks to the relevant senior management and governance bodies, as appropriate.
  • Maintain appropriate level of expertise in US and international GCP/GLP/PV regulatory requirements, policies, SOPs and unit/project-specific procedures within Janssen applicable to the processes and systems within the scope of the R&D QMS.
  • Support key business partners and stakeholders to liaise between quality groups, and governance to enable and promote quality, accountability and quality culture.

Qualifications
  • A minimum of a Bachelor of Science (BSc) (or equivalent degree) is required.
  • A minimum of 8 years of relevant experience in a medium to large scale matrix organization within the Pharmaceutical, Medical Device, and/or Consumer/OTC sector.
  • Knowledge of global GxP compliance regulations governing clinical development activities is required.
  • Extensive knowledge of quality and risk management terminology and proficient knowledge of scientific terminology is required.
  • Strong knowledge of the CAPA process is required.
  • Ability to operate in a matrix environment and influence and colleagues cross functionally on a regular basis is required.
  • Excellent organizational, analytical, strategic, interpersonal, written and oral skills required.  
  • Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment is required.  
  • Demonstrated strength in influencing and negotiation skills and ability to communicate effectively at all levels of the organization is required.
  • This position can be based in Raritan, NJ; Titusville, NJ; Springhouse, PA; Horsham, PA; High Wycombe, England or Beerse, Belgium and may require up to 10% travel depending on the location of the role. 
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
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
00001C5U