Janssen Research and Development, L.L.C., a member of Johnson and Johnson’s Family of Companies, is recruiting for a Manager, Risk Management, Quality Planning & Strategy position within the BioResearch Quality & Compliance (BRQC) organization. This role will support the Cardiovascular Metabolism therapeutic area. The position will ideally be located in Spring House, PA; Raritan, NJ; Titusville, NJ; Beerse, Belgium; Leiden, Netherlands; or High Wycombe, UK. May consider other US locations including remote.
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.
Main responsibilities will include, but are not limited to:
• Develops and executes the Integrated Quality Plan (IQP), with guidance from the QP&S IQP leader and/or the Program Leader.
•Develops, maintains and execute trial oversight activities for assigned trials/indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
• Actively participates in pre-study activities, contributing to the identification of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.
• Ensures that selection of investigator sites balances benefits against potential risks and that rationale for decisions are well documented.
• Monitors risks and mitigations during study execution. Prepares periodic reports assessing critical to quality parameters for the trial and reviews these reports with applicable clinical team members to evaluate pre-defined areas of risk and/or identify new areas of risk.
• Responds independently to GCP-related compliance inquiries from clinical team members and other departments on an ongoing basis. Liaises with other members of BRQC, as appropriate, to ensure alignment and consistency with guidance provided.
• Facilitate Quality Working Group (QWG) meetings.
• Assists/Lead in the development of materials for Stage Gate Review, as needed.
• Develops and executes strategy to ensure inspection readiness for the clinical trial, and provides support during sponsor-monitor inspections, as needed.
• Manages escalation of significant quality issues according to company policy and SOPs and in collaboration with the clinical team and ensures timely issue resolution.
• Consults with appropriate business partners and peers within BRQC to develop and implement Corrective and Preventative Action Plans (Self-Identified, Inspection)
• Contributes to regular status reports to BioResearch Quality & Compliance (BRQC) management, as needed.
• Consults independently on questions related to research quality and compliance from other departments and confers with other QP&S staff, and other colleagues as needed, to ensure consistent interpretation of international regulations and policy.
• Participates in QP&S, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that support key activities.
• Trains or mentors peers and new employees, as needed.
• Minimum Bachelor’s degree is required; Advanced degree preferred. Degree concentration in a scientific, medical or related discipline preferred.
• A minimum of 8 years of experience working in healthcare (pharmaceutical industry and/or healthcare/hospital system or related) required.
• Pharmaceutical industry experience required.
• GCP quality and/or clinical trials experience is required.
• Experience with fundamentals of clinical trial risk management preferred.
• Experience with ICH guidelines are preferred.
• Experience in Quality Management and Compliance functions preferred.
• Strong project management skills preferred.
• Experience collaborating in a cross-functional team environment required.
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) preferred.
• Ability to analyze & interpret collective data to provide insights to drive decision-making preferred.
• Strong 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.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills required.
•Proficient in speaking and writing the country language and English required.
• Flexibility to respond to changing business needs required.
• Proficient in Microsoft Office Applications required.
•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-
United States, Netherlands-South Holland-Leiden, United States-New Jersey-Titusville, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe
Janssen Research & Development, LLC (6084)