Join to apply for the Specialist, QA Clinical Auditor role at Johnson & Johnson Innovative Medicine.
Johnson & Johnson Innovative Medicine is dedicated to building a world where complex diseases are prevented, treated, and cured through innovative healthcare solutions.
Job Description
In R&D Quality, we invest in talent to make quality a business differentiator. The QA Clinical Auditor will conduct risk‑based audits to ensure compliance with GCP and regulatory requirements.
Responsibilities
* Lead the planning, conduct, and reporting of GCP QA routine audits, and support non‑routine GCP audits such as Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, and local operating country audits.
* Apply standard procedures, audit tools, and audit plans accurately during audit activities.
* Analyze, interpret data, and identify patterns and trends in audit data sets.
* Ensure timely review and delivery of CAPAs and actions arising from audits.
* Present audit information clearly, both verbally and in writing, including audit reports.
* Support the GCP audit strategy, especially QA risk‑based auditing approach.
* Assist with regulatory inspections in various supporting roles.
* Complete assigned training requirements to maintain inspection readiness.
* Assist in preparing training material when requested.
* Participate in projects or serve on teams as assigned.
* Meet priorities, checkpoints, and timelines for all work and projects.
Qualifications / Requirements
* Minimum Bachelor's degree; advanced degree in a scientific, medical, or related field preferred.
* Experience in Clinical Quality & Compliance, Clinical Operations, or related R&D area.
* Knowledge of the drug development process, regulations, and scientific quality terminology.
* Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g., FDA regulations, EU CTR, ICH E6 R3).
* Understanding of clinical trial risk management fundamentals.
* Broad knowledge of SOP management, good documentation practices, and records management.
* Digital literacy and analytics experience with standard applications, systems, and data analytics tools.
* Strong planning and prioritization skills, capable of working under time constraints.
* Fluency in English, both spoken and written.
* Willigness to travel up to 30% domestically or internationally.
What You Can Expect
* Application review: Our recruitment team will evaluate your CV for fit.
* Initial call: Qualified candidates will be invited for a short call to discuss the role and answer questions.
* Process updates: You’ll receive regular updates throughout the recruitment process.
* Pre‑start checks: Successful candidates will complete country‑specific checks before starting.
* Feedback survey: After the process, we’ll ask you to share feedback via a short survey.
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