Pharmacovigilance Qa Emea Auditor

Johnson & Johnson Johnson & Johnson · Pharma · Allschwil, Basel-Country, Switzerland

Johnson & Johnson is seeking a Pharmacovigilance QA EMEA Auditor Specialist to enhance quality across the company through pharmacovigilance audit and business partner collaboration. Responsibilities include planning, conducting, and reporting on audits of pharmacovigilance activities, data, internal facilities, and processes in GxP areas, as well as supporting non-routine audits and regulatory inspections. The role also involves project management and providing consultation to business partners on compliance inquiries.

What you'd actually do

  1. Leads the planning, conduct and reporting of Pharmacovigilance routine audits
  2. Supports non-routine Pharmacovigilance audits of activities, data, internal facilities and processes in GxP areas
  3. Participates in projects or serves on teams, as assigned by supervisor.
  4. Supports regulatory inspections in various supporting roles.
  5. Provides consultation to business partners on routine tasks with occasional supervision.

Skills

Required

  • Bachelor’s or equivalent University degree required; Focused degree in natural/biological sciences or equivalent
  • Strong verbal and written communication skills, including presentation skills
  • Strong teamwork and analytical skills
  • Ability to work effectively as part of a collaborative team
  • Fluency in English

Nice to have

  • Minimum of 2 years’ experience in a GVP-regulated environment is preferred, with demonstrated exposure to Pharmacovigilance activities.
  • Business Alignment
  • Business Savvy
  • Coaching
  • Communication
  • Compliance Management
  • Continuous Improvement
  • Fact-Based Decision Making
  • Human-Centered Design
  • ISO 9001
  • Issue Escalation
  • Problem Solving
  • Quality Control (QC)
  • Quality Management Systems (QMS)
  • Quality Standards
  • Regulatory Environment
  • Standard Operating Procedure (SOP)

What the JD emphasized

  • GxP areas
  • Pharmacovigilance