GCP Senior Auditor - Vernon - Scimax Consulting

    Scimax Consulting
    Scimax Consulting Vernon

    6 days ago

    Description

    Location:
    Paramus, New Jersey (Hybrid: 3 days onsite Tuesday to Thursday)

    Education:
    Bachelor's Degree in Scientific, Healthcare, or Related Field

    Experience:
    Minimum 5+ years in the Pharmaceutical or Biopharmaceutical Industry


    Travel:
    Up to 10%

    About the Opportunity
    Join a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies.

    As a GCP Senior Auditor, you will play a key role in ensuring GXP compliance with global regulatory authorities, driving company-wide compliance initiatives, and strengthening quality management systems to minimize risk in a regulated environment.

    This role is ideal for a detail-oriented professional with strong Good Clinical Practice (GCP) experience and a passion for maintaining high-quality standards across global clinical operations.

    Key Responsibilities
    Audit Leadership & Compliance Oversight


    • Plan, conduct, and manage global clinical process and vendor audits across multiple trials.
    • Execute internal and external GXP audits, ensuring adherence to FDA, EMA, and ICH GCP guidelines.
    • Collaborate with clinical sourcing, supplier quality, and clinical partnerships to evaluate and manage CROs, CMOs, investigator sites, and other vendors.
    • Audit clinical systems (IRT, EDC, etc.) with relevant subject matter experts.
    Quality Management & Risk Mitigation


    • Develop detailed audit reports and manage related non-conformance items.
    • Ensure alignment with corporate Quality Management Systems (QMS) and Standard Operating Procedures (SOPs).
    • Support regulatory inspections by preparing documentation and participating in audit readiness activities.
    • Participate in quality improvement initiatives across Clinical Development and Safety/Pharmacovigilance functions.
    Required Qualifications


    • Bachelor's degree in a scientific, healthcare, or related discipline.
    • Minimum 5+ years of experience in the pharmaceutical or biopharmaceutical industry.
    • Strong background in GCP auditing and safety/pharmacovigilance.
    • Demonstrated experience conducting and managing internal and external GXP audits.
    • Proven knowledge of FDA, EMA, and ICH GCP regulatory requirements.
    • Familiarity with QMS, SOPs, and compliance documentation.
    • Experience auditing CROs, CMOs, investigator sites, and clinical vendors.
    • Proficiency auditing clinical systems such as IRT and EDC.
    Preferred Qualifications


    • Experience within a biopharmaceutical organization focused on neurology or psychiatry therapeutic areas.
    • Strong communication and stakeholder engagement skills.
    Additional Details

    Hybrid schedule: 3 days on-site (Tuesday Thursday) in Paramus, NJ.


    • Flexibility required as the on-site schedule may adjust over time.
    • Up to 10% travel may be required for audits and inspections.
    Interested in learning more?

    Send your resume or a message to (Attn: Jacqueline) using the job title GCP Senior Auditor Paramus as your reference.


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