Johnson & Johnson

Director, Cross TA Clinical Risk Management

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Allschwil • Switzerland

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Oversee the execution of data-driven, risk-based trial and program oversight activities
  • Manage a team of CRM representatives that will provide consistent quality oversight
  • Provide and lead strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies
  • Approve CQP (Clinical Quality Plans) risk monitoring information
  • Independently drive quality risk monitoring reviews and coach others
  • Ensure a strategic communication framework with business partners and quality management governance
  • Communicate and facilitate risk updates to R&D Business Partners
  • Develop and ensure a consistent interpretation of issues that require quality investigations
  • Provide guidance for significant quality issues (SQI)
  • Provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans
  • Independently lead key inspection processes and inspection tools
  • Provide remote support for investigational site inspections
  • Provide independent advice on questions related to research quality and compliance
  • Participate in CRM, cross-RDQ JJIM, cross-functional, or cross-sector working groups
  • Work with limited supervision, independently making quality decisions

Requirements

  • A minimum of a Bachelor’s degree (scientific, medical, or related discipline)
  • A minimum of 10 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system)
  • Demonstrates experience or recognizes potential for people leadership in formal or informal setting
  • Proven strong GCP Quality and/or clinical trials experience
  • Excellent interpersonal, oral, and written communication skills
  • Flexibility to respond to changing business needs
  • Demonstrated ability to operate in an environment of culturally diverse styles and business approaches
  • Proficiency in Microsoft Office Applications
  • Experience with fundamentals of clinical trial risk management (preferred)
  • Health Authority Inspection experience (FDA, EMA, and other inspectorates) (preferred)
Benefits
  • Inclusive work environment
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GCP Qualityclinical trialsrisk managementCorrective and Preventative Action (CAPA) Plansquality investigationsrisk assessmentsrisk monitoringinspection processesquality risk monitoring reviewsquality oversight
Soft Skills
people leadershipinterpersonal communicationoral communicationwritten communicationflexibilitycultural diversity awarenessstrategic guidancecoachingindependent decision makingfacilitation