At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**Job Function: **
Quality
**Job Sub Function: **
Quality & Compliance Audit
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine, we are uniquely positioned to innovate across full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every
step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Position Overview
Johnson & Johnson IM is currently recruiting for a Pharmacovigilance QA Auditor Specialist.
As a Pharmacovigilance QA EMEA Auditor Specialist, you will be part of a dynamic global team working to enhance quality across the Company through pharmacovigilance audit and business partner collaboration.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Italy, Belgium, France, Spain - Requisition Number: R-075343
Switzerland - Requisition Number: R-075300
UK - Requisition Number: R-075343
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Key Responsibilities:
Auditing
- Leads the planning, conduct and reporting of Pharmacovigilance routine audits
- Supports non-routine Pharmacovigilance audits of activities, data, internal facilities and processes in GxP areas
Project Management
- Participates in projects or serves on teams, as assigned by supervisor.
Inspection Support
- Supports regulatory inspections in various supporting roles.
Training & Development
- May assist in the preparation of training material if requested.
Subject Matter Expert / Point of Contact
- Provides consultation to business partners on routine tasks with occasional supervision.
- Cooperates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.
Qualifications
Education:
Bachelor’s or equivalent University degree required; Focused degree in natural/biological sciences or equivalent
Experience and Skills:
Required:
- A Minimum 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
Preferred:
- Minimum of 2 years’ experience in a GVP-regulated environment is preferred, with demonstrated exposure to Pharmacovigilance activities.
Other:
- This position requires 10%-30% domestic and international travel
**Required Skills: **
Preferred Skills:
Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Audit Reporting, Business Behavior, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Detail-Oriented, Problem Solving, Quality Control (QC), Quality Standards, Regulatory Environment