Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for a Director, Risk Management, BioResearch Quality & Compliance to be based at either the Raritan, NJ; Titusville, NJ; or Spring House, PA Janssen sites.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Director, Risk Management, is a member of the Quality Planning & Strategy group in BioResearch Quality & Compliance (BRQC) Janssen. This role will lead the implementation and continuous improvement of a framework to proactively identify, assess, and manage quality and/or compliance risk within the Janssen R&D portfolio. This role will establish and maintain standards to ensure consistent application of the framework across therapeutic areas, and flexible application of the framework based on the phase of development, nature of the business objectives, and other key risk factors. This role will ensure that risk management is embedded end to end in the product development lifecycle, incorporating consideration for all GxP risk types. The role will also be accountable to establish a common understanding of risk management principles, serving as the subject matter expert for risk management-related training and development of staff and as the single point of contact to resolve key questions and issues.
Main responsibilities will include, but are not limited to:
• Lead the implementation and further development of processes, systems, and tools supporting integrated Risk Management and the Integrated Quality Plan (IQP).
• Expand the concepts of risk management and IQP to all areas of R&D and phases of product lifecycle.
• Ensure consistent application of the integrated Risk Management framework across therapeutic areas. Ensure that appropriate knowledge management and knowledge transfer activities exist across BRQC to continuously improve organizational competency and refine key processes.
• Establish standard expectations for training and documentation of risk management.
• Embed the IQP as a standard component of regulatory submissions. Develop and execute a strategy to promote the value of the BRQC Janssen risk management process and the IQP within J&J and externally.
• Contribute to the development of, and oversee the maintenance of, IT systems and tools that support risk management and the IQP.
• Liaise across the J&J Enterprise Quality functions and across Janssen R&D to ensure the BRQC Janssen risk management framework is fully aligned and integrated with other existing practices, as applicable.
• Serve as a single point of contact and subject matter expert for BRQC Janssen risk management and the IQP.
• Support core strategic business objectives through execution of IQP to assure appropriate quality oversight and CAPA oversight.
• Mentor individuals in the BRQC Janssen Quality Planning & Strategy team.
• Manage individual programs across the Janssen R&D portfolio, as needed.
• Attend QP&S Leadership Team meetings as needed to discuss risks and opportunities and plan resources to support process updates, training and development, system changes or upgrades, or other enhancements needed to maintain the framework and IQP template.
• Establish and lead mechanisms for knowledge management, including communities of practice.
DECISION-MAKING AND PROBLEM-SOLVING:
This role is expected to make decisions independently or lead consensus decisions within the matrix organization to continually improve and maintain the risk management framework, processes, systems, and organizational competency. This role will be accountable to address significant obstacles and challenges to implementation and full integration of the risk management framework and full adoption of the IQP across regulatory submissions.
INDEPENDENCE / AUTONOMY:
This leader will act with minimal guidance and direction from his/her supervisor. He or she will work independently to meet pre-defined goals and objectives, and will be expected to communicate proactively with his or her supervisor and QP&S management to ensure adequate resources exist to meet objectives.
This position reports to the TA Head for Oncology, Early Development, Medical Affairs and Established Products, Quality Planning & Strategy, BioResearch Quality & Compliance Janssen
RESPONSIBILITY FOR OTHERS
This position has no direct reports. As a key SME within the organization, this position will be responsible to contribute to the training and development of multiple employees, and may serve as a mentor for certain individuals.
Principal Relationships Inside the Companies
This leader will interact with individual employees and senior leaders within BRQC Janssen as well as key Pharma segment R&D functional partners including (but not limited to): Project Management Office, Medical Safety, Global Regulatory Affairs, Global Clinical Development Operations, Therapeutic Areas, and Clinical Supply Chain. May interact with individual employees and management in other J&J segments if necessary.
Principal Relationships Outside the Companies
This leader may interact with global regulatory authorities, industry trade associations, and/or quality, R&D, and medical safety professionals in third-party organizations and marketing partners, as needed.
• A Bachelor’s degree (Science or Business preferred) or equivalent is required
• A minimum of 10 years of experience in the healthcare industry or a related field is required
• A minimum of 3 years of experience leading implementation of risk management principles in an industrial environment
• Requires experience working across multidisciplinary areas of preclinical and clinical development (including pre- and/or post-commercial activities)
• Experience managing or overseeing multiple projects simultaneously is required
• Experience making decisions independently and driving decisions within a matrix environment is required
• Experience working with director level (or higher) leadership to resolve operational issues that may impact critical deliverables, long term strategic plans, or general company reputation
Experience and Skills:
• Strong knowledge of the drug development process, international risk management standards and scientific and quality terminology
• Knowledge of GxP regulations and guidance
• Proactive strategic thinker with strong innovative problem solving skills
• Strong networking and relationship building skills
• Strong interpersonal skills with demonstrated history of collaboration across multiple functional areas
• Conflict management/negotiation/influencing skills
• Written and verbal communications skills
• Presentation skills and experience
• Experience working with multidisciplinary functional leaders (director level and above)
Technology experience and skills:
• Excellent knowledge of English is required
• Proficient in Microsoft Office applications• Up to 25% domestic/international travel