11 ago - Milano
Altro
Job Function Quality
Job Sub Function Quality Assurance
Job Category Professional
All Job Posting Locations Beerse, Antwerp, Belgium, Duelmen, Germany, Issy-les-Moulineaux, France, Madrid - Lafinca, Milano, Italy, Warsaw, Masovian, Poland
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 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
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 support, and continuous enhancement of risk-based auditing practices.
Additional Responsibilities Include Leading routine GCP QA audits and supporting non-routine audits, including due diligence, for-cause, cross-functional, and complex audit activities
Applying standard procedures, audit tools, and audit plans during audit execution
Analyzing and interpreting data and identifying patterns and trends that support quality oversight activities
Supporting timely review and follow-up of CAPAs and audit‐related actions
Preparing clear and concise audit reports and presenting information effectively both verbally and in writing
Contributing to GCP audit planning activities, including risk‐based audit approaches
Supporting regulatory inspections in assigned support roles
Maintaining training requirements to support inspection readiness
Assisting with development of training materials, when requested
Participating in projects and cross‐functional teams as assigned
Managing priorities, timelines, and project deliverables to support business objectives
Supporting the application of digital tools, analytics, and AI‐enabled approaches, where appropriate
Qualifications / Requirements Bachelor's degree required
Advanced degree in a scientific, medical, or related discipline is preferred
Experience in Clinical Quality & Compliance, Clinical Operations, or another relevant R&D; function is required
Knowledge of the drug development process, applicable regulations, R&D; practices, and scientific and quality terminology
Knowledge of Good Clinical Practice (GCP) requirements and applicable regulations and guidelines, including FDA regulations, EU CTR, and ICH E6 R3
Understanding of clinical trial risk management principles
Knowledge of standard operating procedures, good documentation practices, and records management
Experience using digital tools, business applications, and data analytics solutions
Ability to analyze information and identify trends and opportunities
Ability to plan, prioritize, and manage work effectively in a time‐sensitive environment
Strong written and verbal communication skills
Ability to present information clearly to a variety of audiences
Ability to collaborate effectively within cross‐functional environments
Fluent in English, both written and spoken
Demonstrates an understanding of AI concepts and frameworks,
including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity
What We Offer We offer a collaborative environment where learning, innovation, and professional development are encouraged.
In this role, you will have the opportunity to work across global teams, contribute to meaningful quality initiatives, and support the development of innovative medicines that help improve patients' lives.
Additional Role Information Up to 30% domestic and/or international travel may be required
Hybrid working model in alignment with J&J; Flex
Our commitment to inclusion At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.
We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.
If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.
Thank you for considering a career with Johnson & Johnson.
Required Skills Preferred Skills Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards The anticipated pay range for this position, in the primary posting location, is: €60 000,00 - €96 255,00
The anticipated pay ranges for additional locations are: [Spain] – The anticipated base pay range for this position is [EUR 43,600.00] – [EUR 70,150.00]
[France] – The anticipated base pay range for this position is [EUR 44,100.00] – [EUR 71,070.00]
[Italy] – The anticipated base pay range for this position is [EUR 39,800.00] – [EUR 64,055.00]
Benefits In addition to base pay, we offer the following benefits*: an annual premio with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‐being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans.
For more information, visit Employee benefits | Supporting well‐being & career growth | Johnson & Johnson Careers.
This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
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