Johnson & Johnson Careers

Pharmacovigilance Supplier Risk Management Senior Specialist

Raritan, New Jersey; Spring House, Pennsylvania; Toronto, Canada; Titusville, New Jersey
Compliance


Job Description

Requisition ID: 7841190618

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Pharmacovigilance (PV) Supplier Risk Management Senior Specialist, reporting to the Director / Associate Director of Vendor Strategy. The role can be located in Raritan, NJ; Springhouse, PA; Titusville, NJ; Toronto, Canada; or in a Janssen Pharmaceutical site in EMEA, APAC or LATAM.

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.JanssenRnD.com for more information.

As the Pharmacovigilance (PV) Supplier Risk Management Senior Specialist, you will:
• Assist in the execution of PV supplier risk management activities to ensure quality of the PV system, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. May lead targeted activities as directed
• Support activities contributing to the review of key risks associated with PV supplier and input to the design of effective mitigation strategies. May support other domains of supplier management activities as assigned
• Prepare periodic reports assessing critical to quality parameters and provide them to applicable stakeholders to support evaluation of pre-defined areas of risk and/or identification of new areas of risk
• Support other duties as assigned (e.g. CAPA development, issue resolution etc.)
• Support development and implementation standard operating procedures (SOPs) for supplier management that align with local regulatory requirements, JnJ standards and internal processes and procedures.
• Provide inputs and takes the lead on quality system improvement initiatives.
• Lead or support supplier qualification, audits and overall management as required.
• Lead and support local / regional or global projects and quality initiatives as required.

Qualifications
• A minimum of a Bachelor’s degree in a scientific field related to Large Molecule or Tissue Culture related bio-pharmaceuticals is required.
• A minimum of 6 years of relevant working experience is required.
• Experience in the bio-pharmaceutical industry in Quality & Compliance or Operations roles is preferred.
• Working experience ensuring compliance to both Health Authority requirements, internal corporate requirements, and business partner requirements is required.
• Must be able to push boundaries and acts as a change agent, collaborate with and inspire others.
• Must be able to work across functional boundaries and senior management levels while creating lasting connections and networks.
• High level of emotional intelligence allowing for negotiation and working through ambiguity, including during times of change or in sensitive situations is required.
• Strong organizational curiosity to challenge the status quo with willingness to try new, unproven ideas is required.
• Demonstrated ability to positively impact productivity and business results is required.
• Must have excellent presentation and communication skills with strong executive presence.
• Must embody core values of servant leadership, curiosity, positivity, rigor, openness and collegiality and be ready to work hard AND have fun.
• Must be able to travel up to 10% of the time, to domestic and international destinations.

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.

IND3

Primary Location
United States-New Jersey-Raritan-
Other Locations
North America-United States-Pennsylvania-Spring House, Asia Pacific, Latin America, Europe/Middle East/Africa, North America-Canada-Ontario-Toronto, North America-United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC (6084)
Job Function
Compliance
Requisition ID
7841190618