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Manager, Risk Management Compliance

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Job Description


Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Manager, Risk Management Compliance based ideally in 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.

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 Manager Risk Management Compliance 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.

Main responsibilities will include, but are not limited to:
• Assess compliance and/or operational risks to develop and enhance the QP&S risk management strategy and overall integrated risk framework
• Develops and evaluates performance data for specified quality, productivity & risk metrics required for management review to identify compliance strengths and/or gaps
• Monitors efficiency of process controls and risk management requirements in compliance to specific Enterprise/ Industry regulations and standards
• Identify compliance issues that require further investigation. Consults with appropriate business partners and peers within BRQC to provide guidance or review and approve CAPA Plans (SQI, Inspection)
• Collaborates with key stakeholders to develop quality compliance dashboards and summaries to drive transparency, progress risk mitigation activities, and monitor mitigation effectiveness
• Lead/manage assessment process to analyze multiple sources of data
• Collaborate and build strong relationships within BRQC and other key R&D stakeholders to obtain data inputs for dashboards and metric templates to promote forward planning and best practices
• 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

ADDITIONAL RESPONSIBILITIES:
• Ability to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
• Desire for continuous learning and the ability to identify, evaluate and implement emerging trends
• Capable of managing multiple projects simultaneously with a high level of independence to ensure timely and accurate completion of activities
• Strong communication skills with a proven ability to effectively engage and manage key internal cross-functional stakeholders as well as external stakeholders (including Health Authorities).
• Strong collaboration, alignment, and influencing skills with the ability to summarize and present results



Qualifications
• Bachelor's degree is required; preferably in a scientific, medical or related discipline.
• A minimum of 5 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 collaborating in a cross-functional team environment required.
• Previous experience with fundamentals of clinical trial risk management and ICH guidelines are 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.
• 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.
• Flexibility to respond to changing business needs required.
• Proficient in Microsoft Office Applications required.
• 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.

Travel ~10%- 15% primarily domestic and/or international required.

Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
1905780385W