Associate Director, Inspection Readiness(Pharmacovigilance)
Location:
Hopewell Township , New Jersey
Posted:
April 02, 2017
Reference:
4416160825/2-en-us

Janssen Research & Development, LLC, a Johnson & Johnson Company, is currently recruiting for an Associate Director, Inspection Readiness, to be located in Horsham, PA or Titusville NJ.

 

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.  

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 

The Associate Director, Inspection Readiness reports directly to the Director of Training and Document Control with responsibility for the monitoring and improving overall Inspection Readiness performance within the Janssen Global Medical organization (GMO) and additionally across its service partnerships with alliance partners, key vendors and major stakeholders within Janssen and  across J&J.  This leader in Compliance Strategy and Analytics (CSA) will be a highly valued member of the team as he/she:  Identifies and establishes strategy for growing organizational capabilities in the area of Inspection readiness; Drives the evolution of Inspection Readiness process to support the Janssen Office of the CMO; Creates enterprise value for the organization to also work end-to-end across segments and business functions as needed.  Inspection readiness includes the identification and integrated view of key governance groups within GMO that contribute to overall inspection readiness. Inputs will be sought from and collaboration will occur with various functional areas including, IPV, the office of the Pharma QPPV, GMS Operations, Therapeutic Area Safety Heads, SPO, R&DQA, R&DQ&C, GRA, Clinical Operations, JSC and other key groups.

 
Responsibilities:
  • Creation of overall governance structure for Inspection Readiness
  • Work with key groups to manage inspection readiness program, priorities and communications
  • Creation and implementation of Inspection Readiness key/leading indicators for GMO
  • Lead and or collaborate to drive key inspection readiness programs for major Health Authorities
  • Ensure that learnings from inspection or audit outcomes (both within and outside Janssen or GMO) are processed and actioned
  • Ensure all logistical audit and inspection readiness activities are implemented, reviewed maintained and sustained
  • Manage direct reports to ensure oversight, development planning and leadership in the area if inspection readiness
  • Coordinate activities with Director of CAPA and Compliance Strategy to ensure strategic direction in the area of inspection readiness
  • Collaboration within GMO functional groups and with end-to-end PV stakeholders including BRQC, GCO and Regulatory Affairs


Qualifications
  • A minimum of a bachelor’s degree is required; An advanced degree is preferred; 
  • A minimum of 9 years related experience is required
  • Pharmaceutical industry experience with Pharmacovigilance knowledge and subject matter expertise highly preferred
  • Demonstrated experience in managing global health inspections and partnering with global health authorities is highly preferred
  •  Demonstrated track record in achievement of business outcomes and a results oriented history required 
  • Experience and demonstrated track-record in organizational development, leadership and managing change across a diverse global organization required
  • People management experience preferred
  • Ability to work successfully in a complex matrix environment is required
  • CAPA and Quality Systems experience preferred


Primary Location
United States-Pennsylvania-Horsham
Other Locations
North America-United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Pharmacovigilance
Requisition ID
4416160825

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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