Janssen Research and Development, L.L.C., a member of Johnson and Johnson’s Family of Companies, is recruiting for Associate Director, 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 Titusville, NJ; Raritan, NJ; Chesterbrook, PA; Spring House, PA; Beerse, Belgium or 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.
The Associate Director Cardiovascular Metabolism Risk Management role in will develop and manage integrated quality plans (IQPs) to support business-critical activities such as health authority submissions to support new molecular entities or new indications for use.
- Execute quality oversight activities as per the IQP plan and work with risk owners across R&D functions to develop effective risk mitigation plans to control risks identified in the IQP.
- Provide input to trial oversight and quality strategies to ensure that issues are identified in the IQP and mitigated early, and that predefined risk mitigation plans in the IQP are executed in a timely fashion and are effective in mitigating the risk to an acceptable level.
- Lead quality working groups (QWGs) to define and refine the IQP. Organize and lead meetings of the QWG to periodically assess quality metrics to determine if risks are adequately defined and controlled under the IQP. Communicate outcomes of QWG meetings to relevant stakeholders including senior management.
- Lead or assist in the early identification, escalation, and resolution of significant quality issues that pose a significant risk to achievement of core company objectives.
- In collaboration with Regulatory Compliance, lead inspection-readiness activities to support health authority submissions. Develop and execute pre-inspection readiness activities for internal Janssen R&D and external parties that contribute to regulatory submissions.
- May manage Site Inspections as well as Sponsor Monitor Inspections outside the three major inspectorates (FDA, EMA, MHRA). Support inspections managed by Regulatory Compliance.
- Leverage quality analytics data and contextualize key quality insights to primary stakeholders and provide quality consultancy. Consult/collaborate with other BRQC functions to harness the single point of contact model to our business partners.
- Consult with appropriate BRQC business partners and peers to provide guidance or review and approve Corrective and Preventative Action Plans (Self-Identified, Inspection). May also develop CAPAs.
- Collaborate with external development partners for joint clinical quality oversight as per clinical quality agreements.
- Provide regular status reports to BRQC management.
- Resolve compliance/regulatory issues with business leaders within the Therapeutic Area (TA)/Disease Area Stronghold (DAS).
- Lead cross-functional teams to determine risk level and make decisions about proper mitigation of risk to ensure submission success.
- Participate in/lead QP&S, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that support key activities.
- Train/coach others with regard to teamwork, interpretation of regulatory requirements, risk management and compliance activities.
QualificationsA Bachelor’s degree is required, preferably in a scientific, medical, or related discipline. A minimum of eight (8) years of experience working in the health care and/or pharmaceutical industry required. Other position requirements include:
- GCP quality and/or clinical trials experience
- Experience collaborating in a cross-functional team environment
- A high degree of accuracy and attention to detail
- Excellent interpersonal, oral, and written communication skills
- Flexibility to respond to changing business needs
- Proficient in Microsoft Office Applications
Preferred Experience Includes
- Experience with fundamentals of clinical trial risk management
- Experience with ICH guidelines
- Experience in Quality Management and Compliance functions
- Strong project management skills
- Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)
- Ability to analyze and interpret collective data to provide insights to drive decision making
- Inspection support experience (FDA, EMA, and other inspectorates/health authorities)
General/soft Skills
- Relationship building
- Negotiation and influencing
- Conflict resolution
- Problem solving
- Strategic thinker
- Ability to create an open environment
Travel RequirementsUp to 25% primarily domestic and/or international travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
United States-Pennsylvania-Spring House, United States-Pennsylvania-Wayne, United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Antwerp
Organization
Janssen Research & Development, LLC (6084)
Job Function
Quality
Requisition ID
2105959907W
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