Manager, Clinical Supplier Risk Management

Jobinhalt

Janssen Research & Development, LLC, part of the Johnson & Johnson Family of companies, is recruiting for a Manager, Clinical Supplier Risk Management, to be located in Springhouse, Pa; Titusville, NJ; Raritan, NJ; Beerse, Belgium; Leiden, Netherlands; or High Wycombe, UK. 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 . PRINCIPAL RESPONSIBILITIES: Main responsibilities will include, but are not limited to: Manage execution of the early development clinical suppliers and alliance partners integrated risk management framework in close collaboration with key business partners to support R&D operations business-critical outsourcing related activities. Key activities include: Identify risks associated with clinical suppliers and capture risks and mitigation plans in a risk management system Collaborate with Janssen R&D and supplier business partners to drive development of risk mitigation activities to manage systemic risks identified with clinical suppliers’ quality management systems and assure all actions are driven to resolution Collaborate with BRQC Janssen Quality Assurance to support the clinical supplier audit program (as needed) Lead quality components related to qualification of new clinical suppliers for assigned supplier types in support of the overall sourcing strategy in collaboration with Janssen R&D business partners Lead periodic quality & compliance meetings with key clinical supplier quality counterparts to monitor the overall quality of the clinical portfolio being managed by the supplier and assure it is being delivered according to contractual and regulatory obligations as assigned by QP&S Leadership Manage development and disclosure of contextualized quality profiles regarding clinical supplier risks for assigned supplier types to key stakeholders. Provide quality consultancy on profiles as needed Collaborate with cross-functional clinical development teams to develop risk mitigation activities for risks identified through execution of clinical activities to manage clinical supplier quality management systems related risks for assigned supplier types Support prompt management of significant quality events related to clinical supplier contractual services in collaboration with relevant clinical trial teams including but not limited to formal escalation, support of CAPA development and/or overseeing execution of risk management activities Support health authority inspections and post-inspection commitments to address requests/commitments related to applicable supplier services as assigned by QP&S leadership Support clinical supplier components of integration plans following a license or acquisition deal and provide relevant risk information to key business partners as assigned by QP&S leadership ADDITIONAL RESPONSIBILITIES: Support PV, technical and other clinical supplier types of risk management activities as assigned by the Director, Clinical & PV Supplier Risk Management Head or designee The ideal candidate for this position: Is passionate about developing new solutions for patients. Naturally pushes boundaries and acts as a change agent, collaborating with and inspiring others. Can work across functional boundaries and senior management levels while creating lasting connections and networks. Has a high level of emotional intelligence allowing for negotiation and working through ambiguity, including during times of change or in sensitive situations. Has strong organizational curiosity to challenge the status quo with a willingness to try new, unproven ideas. Has demonstrated ability to positively impact productivity and business results. Has excellent presentation and communication skills with a strong executive presence. Embodies core values of servant leadership, curiosity, positivity, rigor, openness and collegiality and is ready to work hard AND have fun. Qualifications Required: A minimum of a bachelor’s degree (or University equivalent) A minimum of 8 years of related R&D experience Experience ensuring compliance to both Health Authority requirements, internal corporate requirements, and business partner requirements This position may require up to 10% domestic and international travel Preferred Experience in the biopharmaceutical industry in Quality & Compliance or Operations roles Project management experience Previous exposure to a role in quality or risk management At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 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 United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Raritan, United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden Organization Janssen Research & Development, LLC (6084) Job Function Quality Requisition ID 2205999688W