Director, External Innovation Risk Management

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Director, External Innovation Risk Management located in either Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; La Jolla, CA, or Tampa, FL.At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.The Director, External Innovation Risk Management is a member of the Quality Planning and Strategy (QP&S) group in BioResearch Quality & Compliance (BRQC) Janssen. This role will foster a positive, collaborative business relationships in order to aid the company with adoption of the Janssen quality management system and defined business operating model. Principal Relationships Inside the CompaniesThis leader will interact with newly acquired companies, Licensing & Collaboration Partners as well as key R&D functional partners including (but not limited to): J&J Innovation Centers, Janssen Business Development, Project Management Office, Medical Safety, Global Regulatory Affairs, Global Clinical Development Operations, Therapeutic Areas, Clinical Supply Chain and Legal. This leader will also interact with individual employees and management in other J&J segments as part of the J&J Innovation Framework.Principal Relationships Outside the CompaniesThis leader may interact with quality, R&D, and medical safety professionals in third-party organizations and marketing partners, as needed.Main responsibilities will include, but are not limited to:

Lead the connection to GEI, LCI and WWDA Operations teams to ensure 1) effective partnership in L&A Due Diligence 2) operational excellence with deal integration

Must be able to build and maintain positive, collaborative relationships with multi-company leaders and functional experts to enable the execution of quality deliverables.

Develop robust L&A portfolio management processes, metrics, & tools (in close collaboration with Key R&D partners, Quality, & Compliance).

Assess new program opportunities, with ability to succinctly capture value, risk, and recommendations for participation.

Provide project management oversight of a cross-company team of functional experts to drive the desired integration model, including planning, execution, escalation and tracking of key quality risks

Complete actions as part of Integration planning in conjunction with Innovation Business Development Deals and key R&D partners, through BRQC L&A processes, that GLP, GCP, medical safety and operational compliance risks are proactively identified and appropriately mitigated throughout the integration period, where applicable.

Must be able to develop mitigation strategies supporting any Innovation Business Development Deal and key R&D partners to assure regulatory risks are appropriately mitigated with acquired companies. Including incorporating best practices for portfolio, program and project management that have impacted business results.

Must be able to interpret and resolve complex GCP, Medical Safety and Operational compliance issues related to the integration of new companies into Janssen’s QMS.

Must be able to think innovatively to resolve operational problems that may arise in development, finalization, and implementation of the quality integration strategy with key business partners and leaders of their functional areas as necessary. Must be able to proactively identify operational roadblocks to integration and work with leaders across companies to expediently address and resolve challenges

Qualifications

A Bachelor’s degree (Science or Business preferred) or equivalent is required. MBA or Master’s degree preferred.

A minimum of 8-10 year’s-experience in a medium to large scale matrix quality organization (operational quality and/or

quality assurance) is required

GCP required or GLP Experience preferred

Requires experience working across multidisciplinary areas of preclinical and clinical development including but not limited to: clinical operations, regulatory operations clinical trial portfolio planning, and project management.

Experience making decisions independently and ensuring confidentiality of business-critical activities is required

Experience working with senior leadership to resolve operational issues impacting critical deliverables required

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 disabilityPrimary LocationUnited States-Pennsylvania-Spring House-Other LocationsUnited States-New Jersey-Titusville, United States-Pennsylvania-Spring House, United States-New Jersey-Raritan, United States-Pennsylvania-Horsham, United States-California-La Jolla, United States-Florida-TampaOrganizationJanssen Research & Development, LLC (6084)Job FunctionR&DRequisition ID7199200626