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 in the United States. Preferred locations include near a US J&J Hub: Chesterbook, PA; Titusville, NJ; Raritan, NJ; Bridgewater NJ; La Jolla, CA. May consider remote US.

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 visibility and reporting across the Quality Planning & Strategy organization.

Drive and improve 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
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)
Develop, in close interaction with key stakeholders, quality compliance dashboards and summaries to drive visibility, progress risk mitigation activities, and monitor mitigation effectiveness
Enable dedicated analysis of multiple sources of data to predict or identify trends that enhance risk management insights and communicate to R&D partners
Collaborate and build positive relationships within BRQC and other key R&D partners to acquire data inputs for dashboards and metric templates to promote forward planning and standard methodologies
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
Track deviations, quality events, and key performance indicators and provides reports to QP&S management on trending, and status as requested.
Ability to interpret problems and effectively resolve appropriate resolutions that ensure compliance and minimize risk
Desire for continuous learning and the ability to identify, evaluate and implement emerging trends
Capable of handling multiple projects simultaneously with a high level of independence to ensure timely and accurate completion of activities
Strong communication skills with a consistent track record to actively engage and manage key internal cross-functional partners as well as external stakeholders (including Health Authorities).
Must possess the ability to partner with associates at all levels of the organization and have strong communication, presentation, interpersonal and influencing skills

Qualifications
Bachelor's degree is required; preferably in a scientific, medical or related subject area.
A minimum of 8 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 and demonstrated technical project leadership capabilities required
Experience working in a cross-functional team environment is required
Previous experience with fundamentals of clinical trial risk management and ICH guidelines are preferred
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 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
Strong knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Clinical Practice (GC) is preferred
Inspection support experience (FDA, EMA and other inspectorates) is preferred.
Travel ~10% primarily domestic and/or international may be required

Work location is flexible if approved by the Company except that position may not be performed remotely from Colorado.

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-Pennsylvania-Spring House-Welsh & McKean Roads
Other Locations
North America-United States, North America-United States-California-La Jolla, North America-United States-New Jersey-Bridgewater, North America-United States-Pennsylvania-Chesterbrook, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC (6084)
Job Function
Quality
Requisition ID
2105908142W