Specialist, Qa Clinical Gcp Auditor

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ph3Job Function /h3pQuality /ph3Job Sub Function /h3pQuality Assurance /ph3Job Category /h3pProfessional /ph3All Job Posting Locations /h3pBeerse, Antwerp, Belgium, Duelmen, Germany, Issy-les-Moulineaux, France, Madrid - Lafinca, Milano, Italy, Warsaw, Masovian, Poland /ph3Job Description /h3h3About Innovative Medicine /h3pOur 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.
/ppJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
/ppLearn more at /ppIn RD 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.
/ppThis hybrid role can be located near a Johnson Johnson office and offers the flexibility of the JJ Flex model.
/ppPlease 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).
/ppBelgium, Spain, France, Italy, Poland, Germany - Requisition Number: R- /ppSwitzerland - Requisition Number: R- /ppUK - Requisition Number: R- /ppWe are searching for the best talent for a Specialist, QA Clinical GCP Auditor.
/ph3Purpose /h3pAre you interested in helping strengthen quality and compliance across global clinical development programs while working with innovative therapies and cross-functional teams?
/ppAs 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.
/ppWe look forward to learning more about you!
/ph3You will be responsible for /h3pIn 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.
/ph3Additional Responsibilities Include /h3ulliLeading routine GCP QA audits and supporting non-routine audits, including due diligence, for-cause, cross-functional, and complex audit activities /liliApplying standard procedures, audit tools, and audit plans during audit execution /liliAnalyzing and interpreting data and identifying patterns and trends that support quality oversight activities /liliSupporting timely review and follow-up of CAPAs and audit?related actions /liliPreparing clear and concise audit reports and presenting information effectively both verbally and in writing /liliContributing to GCP audit planning activities, including risk?based audit approaches /liliSupporting regulatory inspections in assigned support roles /liliMaintaining training requirements to support inspection readiness /liliAssisting with development of training materials, when requested /liliParticipating in projects and cross?functional teams as assigned /liliManaging priorities, timelines, and project deliverables to support business objectives /liliSupporting the application of digital tools, analytics, and AI?enabled approaches, where appropriate /li /ulh3Qualifications / Requirements /h3ulliBachelor's degree required /liliAdvanced degree in a scientific, medical, or related discipline is preferred /liliExperience in Clinical Quality Compliance, Clinical Operations, or another relevant RD function is required /liliKnowledge of the drug development process, applicable regulations, RD practices, and scientific and quality terminology /liliKnowledge of Good Clinical Practice (GCP) requirements and applicable regulations and guidelines, including FDA regulations, EU CTR, and ICH E6 R3 /liliUnderstanding of clinical trial risk management principles /liliKnowledge of standard operating procedures, good documentation practices, and records management /liliExperience using digital tools, business applications, and data analytics solutions /liliAbility to analyze information and identify trends and opportunities /liliAbility to plan, prioritize, and manage work effectively in a time?sensitive environment /liliStrong written and verbal communication skills /liliAbility to present information clearly to a variety of audiences /liliAbility to collaborate effectively within cross?functional environments /liliFluent in English, both written and spoken /liliDemonstrates 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 /li /ulh3What We Offer /h3pWe offer a collaborative environment where learning, innovation, and professional development are encouraged.
/ppIn 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.
/ph3Additional Role Information /h3ulliUp to 30% domestic and/or international travel may be required /liliHybrid working model in alignment with JJ Flex /li /ulh3Our commitment to inclusion /h3pAt Johnson Johnson, we believe health is everything.
Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.
/ppWe are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.
/ppIf you require a reasonable accommodation during the application, interview, or onboarding process, support is available.
Please let us know how we can help.
/ppThank you for considering a career with Johnson Johnson.
/ph3Required Skills /h3h3Preferred Skills /h3pBusiness 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 /ph3The anticipated pay range for this position, in the primary posting location, is: /h3p€******,00 - €******,00 /ph3The anticipated pay ranges for additional locations are: /h3p(Spain) – The anticipated base pay range for this position is (EUR 43,******) – (EUR 70,******) /pp(France) – The anticipated base pay range for this position is (EUR 44,******) – (EUR 71,******) /pp(Italy) – The anticipated base pay range for this position is (EUR 39,******) – (EUR 64,******) /ph3Benefits /h3pIn 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.
/pulliThis is for informative purposes only.
Amounts and actual benefits may vary by location and are subject to change.
/li /ul /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cxei0