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.
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.
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.
are Janssen. Our mission drives us. Our patients inspire us. We collaborate
with the world for the health of everyone in it.
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
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
- Monitor and track GMS audit and inspection participation
- Oversight and development of GMS Inspection Readiness
Metrics/Dashboards for presentation to GMSO Operational Performance
- Facilitate communications to GMSO and applicable GMS (e.g. MSSI,
MSA, etc.) leadership on ongoing/upcoming CAPA records and
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.
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
- 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
- Other duties as assigned.
- Management of GMSO Archiving activities
in compliance with internal records management standards to support vital
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.
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
- Advanced degree preferred.
Bachelor’s degree required
- At least 6 years’ relevant experience
- 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
- 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
United States-Pennsylvania-HorshamOther Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
Drug & Product Safety Operations