Manager, Safety Readiness, Global Medical Safety Operations (GMSO)
Location:
Horsham , Pennsylvania
Posted:
January 31, 2017
Reference:
000018DX/1-en-us

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Global Medical Safety Operations (GMSO) Safety Readiness. This position can be based in the following locations: Horsham, PA; Raritan NJ; High Wycombe UK.

 

 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 Manager, Global Medical Safety Operations (GMSO) Safety Readiness is responsible for developing and executing the GMS inspection readiness program and is a subject matter expert in inspection readiness. The Manager is responsible for supporting the CAPA commitment program, including tracking of audit/inspection/CAPA activities and the generation of associated metrics. The Manager will have working process knowledge and will support GMSO or other assigned deliverables as required. The Manager will partner with GMS team members, stakeholders, and Subject Matter Experts (SMEs) to continuously improve GMS state of inspection readiness.

 

The Manager will also work closely with functional area representatives to support the business, act as GMS liaison during audit/inspection, and may serve as delegate for their manager.


Responsibilities:


GMS Inspection Readiness Program

  • Establish and execute audit readiness and proactive practices for GMS including operational process monitoring (“spot checks”) to ensure functional area compliance and documentation inspection readiness.
  • Liaise with Compliance Standards and Analytics (CSA) and maintain the GMS SMEs list regarding audit/inspection readiness; act as GMS liaison during inspection/audit
  • Monitor and track GMS audit and inspection participation
  • Oversight and development of GMS Inspection Readiness Metrics/Dashboards for presentation to GMSO Operational Performance leadership.
  • Facilitate communications to GMSO and applicable GMS (e.g. MSSI, MSA, etc.) leadership on ongoing/upcoming CAPA records and audit/inspections.
  • Coordinate SME audit and inspection training in collaboration with CSA.

Support the development, tracking, trending and execution of all CAPA commitments assigned for GMS.

  • Provide Business Support of CAPA commitments assigned to GMS to ensure CAPAs authored by functions are robust and inspection ready
  • Ensure appropriate GMS stakeholder participation within CAPA development through to CAPA resolution.
  • Provide operational/business technical guidance, additional SME recommendations, consultation on query requests to CAPA Owners.
  • Ensure generation of CAPA metric presentation/dashboard, CAPA escalation and tracking for presentation to the GMS Leadership/Governance Committee.
  • Provide individual CAPA summaries for assigned CAPAs.
  • Ensure tracking of assigned CAPA Owner Event/Deviation/CAPA presentation to ensure timeliness of review/approval by of GMS functional area leader, stakeholders, Leadership team(s) etc. to meet PV CAPA Center of Excellence (COE) timelines.
  • Author summaries for individual CAPAs
Department initiatives
  • Participate in department and/or cross-functional initiatives as appropriate
  • Collaborate with team members and stakeholders to ensure a consistent approach to deliverables and across department.
  • Other duties as assigned.
  • Management of GMSO Archiving activities in compliance with internal records management standards to support vital record retrieval.
Decision Making/Problem Solving
  • Knowledge of case processing as well as basic aggregate reporting. Daily application of in-depth regulatory and medical knowledge, J&J Credo, database knowledge, SOPs and ethics to evaluate and handle any situation in a particular PV operations.
  • Apply a comprehensive understanding of international PV regulations, GMS SOPs and policies, procedures, and select tasks. These tasks are technical in nature.
  • Good communication and writing skills demonstrated by the ability to provide stakeholder comments promptly and clearly as well as compile and present data to other professionals.
  • Recognize potential gaps/issues and/or compliance issues and make decision about the appropriate course of action to take.
  • Requires management skills for multidisciplinary interactions and coordination. Facilitates resolution of complex issues and must manage stakeholders at varying levels of management across multiple organizations. Requires a level of skill in managing difficult situations constructively.
  • Requires strong analytical skills to examine data and perform analysis
  • Ability to understand stakeholder/customer needs
  • High level of flexibility and ability to (re)prioritize work
  • Attention to detail and ability to analyze data in broader context


Qualifications
  • Advanced degree preferred.  Bachelor’s degree required
  • At least 6 years’  relevant experience is required
  • Experience in Pharmacovigilance, Clinical Profession or allied field with CAPA or inspection readiness oversight and operational experience in a multi-functional organization is required
  • Demonstrated ability of coordinating multi-functional activities in a highly regulated environment resulting in concrete business results required
  • Experience in Quality Management, Project Management and/or Process Excellence concepts and practices is preferred
  • Strong knowledge and experience with pharmacovigilance (safety) processing/reporting and regulatory compliance issues is required
  • Previous leadership experience is preferred


Primary Location
United States-Pennsylvania-Horsham
Other Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Operations

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