Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Associate Director, Risk Management Compliance Operations based ideally in NJ or PA. Ideal locations include Titusville, NJ; Raritan, NJ; Spring House, PA; Horsham, 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 http://www.janssen.com for more information.
The Associate Director, Risk Management Compliance Operations is responsible to support the implementation and continuous improvement of BioResearch Quality & Compliance (BRQC) risk management framework within the Janssen R&D portfolio. This role will establish and maintain standards to ensure consistent approach across therapeutic areas, and flexible application based on the phase of development, nature of the business objectives, and key risk factors. The incumbent will also drive transparency and reporting across the Quality Planning & Strategy organization.
• Drive and improve oversight strategies to ensure compliance through the integrated risk management framework and quality compliance programs
• Develops and evaluates performance data for specified quality, efficiency & risk metrics required for management review to identify compliance strengths and/or gaps
• Monitors department’s adherence to implemented process controls and risk management requirements in compliance to specific Enterprise/ Industry regulations and standards
• Consults with appropriate business partners and peers within BRQC to provide guidance or review and approve CAPA Plans (SQI, Inspection)
• Develop, in close interaction with key stakeholders, quality compliance dashboards and summaries to drive transparency, progress risk mitigation activities, and monitor mitigation effectiveness
• Lead Quality Planning & Strategy leadership team meetings as the decision support lead.
• Lead/manage assessment process to analyze multiple sources of data
• Collaborate with BRQC QANA and other key R&D stakeholders to build templates/score cards/ dashboards for functional team
• Lead periodic quality & compliance meetings with key quality counterparts to monitor overall compliance to risk management activities with the clinical portfolios and therapeutic areas
• Support core strategic business objectives through execution of risk management strategy to assure appropriate quality oversight
• Provides status reports and /or executive summaries to QP&S management and key stakeholders
• Liaise with QP&S Leaders, R&D leadership, Governance and Operations and other BRQC teams to effectively communicate the complexity of risks and issues
• Ability to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
• Manages projects with a high level of independence to ensure timely and accurate completion of activities
• Strong communication skills with a confirmed ability to effectively engage and balance key internal cross-functional internal and external business partners (including Health Authorities).
• Strong collaboration, alignment, and influencing skills with the ability to summarize and present results
• Bachelor's degree is required; preferably in a scientific, medical or related discipline. Advanced degree preferred.
• A minimum of 8 years of experience working in the health care industry required; pharmaceutical industry preferred.
• Experience in Quality Management and Compliance functions preferred.
• GCP quality and/or clinical trials experience is preferred.
• Strong project management skills required.
• Experience leading and influencing complex, cross-functional team required.
• Previous experience with fundamentals of clinical trial risk management and ICH guidelines are required.
• Proficient with data visualization tools (i.e., Tableau, Spotfire, or related) preferred.
• Ability to analyze & interpret collective data to provide insights to drive decision-making.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills required.
• Flexibility to respond to changing business needs required.
• Proficient in Microsoft Office Applications required.
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Inspection support experience (FDA, EMA and other inspectorates) is preferred.
• Travel ~10%- 15% primarily domestic and/or international required.
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.
United States-New Jersey-Raritan-
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, North America-United States-Pennsylvania-Horsham
Janssen Research & Development, LLC (6084)