Janssen research and development, l.l.c., a member of johnson and johnson`s family of companies, is recruiting for an associate director, risk management compliance data lead based in the united statesPreferred locations include near a us j&j hub: chesterbrook, pa; titusville, nj; raritan, nj; bridgewater nj; la jolla, caMay consider remotely based in us.
At the janssen pharmaceutical companies of johnson & johnson, what matters most is helping people live full and healthy livesWe focus on treating, curing and preventing some of the most devastating and complex diseases of our timeAnd 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 diseasesPlease 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 & complaince (brqc) risk management framework within the janssen r&d portfolio and cross-segment support (consumer, medical devices)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 factorsThe incumbent will also drive transparency and reporting across the brqc organization.
Drive and enhance 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
Supervises department’s adherence to implemented process controls and risk management requirements in compliance to specific enterprise/ industry regulations and standards
Engage and partner with brqc organization to identify progressive risk management methodologies utilizing technology and ai- based analytic strategies
Advance identification and application of risk management tools and technology
Enable dedicated analysis of multiple sources of data to predict or identify trends that enhance risk management insights and communicate to r&d partners
Coordinate and lead risk management compliance efforts in metric generation to support quality system management review, aggregate analysis, and other compliance forums
Liase, partner and build positive relationships with brqc qana and other key r&d partners to acquire data inputs for dashboards and metric templates to promote forward planning and standard methodologies
Develop, in close interaction with key partners, quality compliance dashboards and summaries to drive transparency, progress risk mitigation activities, and monitor mitigation effectiveness.
Support core strategic business objectives through execution of risk management strategy to assure appropriate quality oversight
Support risk management leaders and/or brqc senior leadership teams by preparing routine updates related to analysis of metrics which require actions to improve or maintain performance compliance metrics
Leads projects with a high level of independence to ensure timely and accurate completion of activities
Qualifications
Bachelor`s degree is required; preferably in a scientific, medical or related fieldMasers or advanced degree preferred.
A minimum of 8 years of experience working in the health care industry required; pharmaceutical industry preferred.
Previous experience with fundamentals of clinical trial risk management and ich guidelines are required.
Experience in quality management and compliance functions preferred.
Strong project management skills required.
Experience leading and influencing complex, cross-functional team required.
Strong data analytics expertise is required
Strong proficiency with ms excel is 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 is required.
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.
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.
Strong communication skills with a confirmed ability to effectively motivate 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
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.
Primary location
United states-pennsylvania-spring house-welsh & mckean roads
Other locations
North america-united states, north america-united states-new jersey-raritan, north america-united states-new jersey-titusville, north america-united states-pennsylvania-chesterbrook, north america-united states-new jersey-bridgewater, north america-united states-california-la jolla
Organization
Janssen research & development, llc (6084)
Job function
R&d
Requisition id
2105965086w
