Specialist, QA Clinical GCP Auditor
Johnson & Johnson
- Location
- High Wycombe, Buckinghamshire, United Kingdom
- Work model
- On-Site
- Level
- Mid
- H-1B history
- 2 approvals (FY2023)
- Posted
- 16h ago
Skills
About this role
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 Assurance Job Category: Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: 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 In R&D Quality, we continue to invest in our talent, diversity, and expertise to make quality a business differentiator and competitive advantage. By working closely with our business partners, we help deliver what matters most to customers and patients. We apply innovative, risk-based audit approaches that provide meaningful insights to help proactively strengthen compliance, sustainability, and reliability across Johnson & Johnson Innovative Medicine. This hybrid role can be located near a Johnson & Johnson office and offers the flexibility of the J&J Flex model. 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): Belgium, Spain, France, Italy, Poland, Germany - Requisition Number: R-091908 Switzerland - Requisition Number: R-092908 UK - Requisition Number: R-092914 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. We are searching for the best talent for a Specialist, QA Clinical GCP Auditor . Purpose Are you interested in helping strengthen quality and compliance across global clinical development programs while working with innovative therapies and cross-functional teams? As a Specialist, QA Clinical GCP Auditor, you will contribute to quality oversight across clinical development activities by supporting and leading Good Clinical Practice (GCP) audit activities. The role helps ensure adherence to corporate policies, internal standards, and applicable regulatory requirements while supporting a risk-based quality approach across Johnson & Johnson Innovative Medicine. We look forward to learning more about you! You will be responsible for In this role, responsibilities include planning, conducting, and reporting routine GCP QA audits and supporting non-routine audit activities. Audit activities may include Clinical Investigator Site audits, Trial and Program audits, External Service Provider audits, Process and System audits, and Local Operating Country audits. Working closely with internal and external partners, the role supports adherence to corporate requirements and applicable regulations while contributing to quality oversight across the clinical development lifecycle. The position also contributes to data analysis, audit strategy activities, inspection