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Associate Director, Compliance Platform Business Process Management
Johnson & Johnson
Raritan, NJ, United States
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Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Compliance Platform Business Process Management, located in Raritan NJ or Springhouse, 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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Position Summary:
The Associate Director in the Tools & Technology group will support or manage one or more technology platforms that make up the quality systems aspect of BioResearch Quality & Compliance (BRQC). This role will partner routinely with colleagues from Information Technology as well as colleagues who serve as business/process owners of our in-scope computer systems and related processes. A primary responsibility of this role and this group is to ensure an integrated platforms approach that accounts for upstream and downstream information flows and reporting needs as well as process/system integrations, as well as to drive common methodologies and integration practices across all of our systems and supported processes. An example of processes supported by in-scope systems would be the tracking of study and solicited activities including but not limited to Clinical Studies, Market Research and Patient Support Programs. The Associate Director role will support these processes and related systems throughout their lifecycle, from development/implementation through support, maintenance, and retirement.
Principle Responsibilities:
• Understand data landscape and related processes, and customer needs for BRQC, Tools and Technology
• Have or develop a deep understanding of how the data captured in in-scope systems supports the relevant process and how the data supports downstream process or decision points
• Develop and execute processes to identify, document, and implement cross-platform data flows and dependencies
• Identify key business rules for the data that supports integrated platforms and ability to report and measure
• Partner across our BRQC platforms to adopt best practices in system implementation, training, business support, and business maintenance
• Identify critical process and system interfaces and connections, and work with IT and systems project teams to ensure that these interfaces and connections are taken into account
• Together with leaders of the Tools & Technology group, create a platform where all of the components work together to support a robust Quality Management System
• Partner with Enterprise Quality Systems across platforms
• Deliver efficiently on critical system implementations
• Develop user communication and training materials as necessary
• Support critical system business administration tasks as necessary
Qualifications
• A minimum of a Bachelor’s degree is required.
• A focused degree in Science, Business, or Computer science / technology or equivalent is preferred.
• A minimum of 8 years of experience in a medium to large scale matrix quality organization (operational quality and/or quality assurance) or equivalent time and experience in a related area (R&D, commercial) is required.
• Knowledge of the pre-clinical and clinical drug development process is preferred.
• Knowledge of Commercial activities i.e, Market Research, and/or Patient Support Programs is preferred.
• Knowledge of pharmacovigilance activities is preferred.
• Excellent knowledge of computer systems, business processes, and data flows is preferred.
• Experience with Quality and Compliance systems is preferred.
• Proficiency in Microsoft Office applications is required.
• Experience working with senior leaders/leadership teams is preferred.
• Excellent knowledge of the English language is required.
• This position will be based in Raritan NJ or Springhouse PA, and may require up to 25% domestic/international travel as business demands.
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.