GCP Auditor/Senior
7 days ago
GCP Auditor/Senior Auditor, Quality AssuranceThe GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's compliance directives. This position supports quality management systems to minimize risks in a regulated pharmaceutical environment. The incumbent will conduct both internal and external GXP audits and provide day-to-day support to the GXP QA Director in clinical operations, non-clinical, and manufacturing processes. This role requires managing CROs, CMOs, investigator sites, and vendors to support clinical trials in a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies.ResponsibilitiesPlan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.Plan and conduct audits of specific clinical processes based on risk.Perform clinical vendor audits alongside various SMEs to assess all services provided by a vendor.Develop audit reports and distribute them to appropriate stakeholders.Own and manage related clinical vendor non-conformances.Review, understand, and audit clinical related regulations and guidelines.Collaborate with clinical sourcing, supplier quality, and clinical partnership to manage clinical vendors.Support the preparation, coordination, and participation of regulatory agency inspections.Participate in and support quality improvement projects.Essential Skills5+ years of pharmaceutical experience.BS degree in scientific, health care, or related discipline.Extensive GCP experience.Experience with both internal and external process and systems audits.Strong knowledge of development policies, procedures, and standards.Ability to work with global clinical teams in developing objectives for audits of clinical studies.10% traveling required.Additional Skills & QualificationsSponsor experience, not only CRO experience.5 years of experience with GCP, TMF audits, system audits, inspection readiness, and CRO audits.2 years of experience in independent auditing.Phase 2 and 3 clinical trial experience is desirable.Work EnvironmentThis position requires a minimum of three days in the office, specifically from Tuesday to Thursday. The team consists of four members, including one GCP auditor and one PV auditor. The company is based in Northern New Jersey and requires on-site presence.Job Type & LocationThis is a Contract to Hire position based out of Paramus, NJ.Pay and BenefitsThe pay range for this position is $64.00 - $68.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a hybrid position in Paramus, NJ.Application DeadlineThis position is anticipated to close on Jan 6, 2026.
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GCP Senior Auditor
1 week ago
Paramus, United States Together We Talent Full timeGCP Senior AuditorParamus, NJ (Hybrid) | Contract | Mid–Senior LevelEnsure GxP compliance, quality oversight, and audit excellence for a fast-growing biopharmaceutical company advancing neurology and psychiatry therapies.A rapidly growing biopharmaceutical organization is seeking an experienced GCP Senior Auditor to support Quality Assurance programs...
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GCP Senior Auditor
2 weeks ago
Paramus, NJ, United States Together We Talent Full timeJob Description GCP Senior Auditor Paramus, NJ (Hybrid) Contract Mid-Senior Level Ensure GxP compliance, quality oversight, and audit excellence for a fast-growing biopharmaceutical company advancing neurology and psychiatry therapies. A rapidly growing biopharmaceutical organization is seeking an experienced GCP Senior Auditor to support Quality Assurance...
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GCP Senior Auditor
2 weeks ago
Paramus, United States Together We Talent Full timeJob DescriptionGCP Senior AuditorParamus, NJ (Hybrid) | Contract | Mid–Senior LevelEnsure GxP compliance, quality oversight, and audit excellence for a fast-growing biopharmaceutical company advancing neurology and psychiatry therapies.A rapidly growing biopharmaceutical organization is seeking an experienced GCP Senior Auditor to support Quality Assurance...
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GCP Auditor/Senior
4 days ago
Paramus, NJ, United States Actalent Full timeGCP Auditor/Senior (Sr.) Auditor, Quality Assurance Apply for the GCP Auditor/Senior Auditor, Quality Assurance role at Actalent. Job Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's...
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GCP Auditor/Senior
1 day ago
Paramus, NJ, United States Actalent Full timeGCP Auditor/Senior (Sr.) Auditor, Quality Assurance Apply for the GCP Auditor/Senior Auditor, Quality Assurance role at Actalent. Job Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's...
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GCP Senior Auditor
3 days ago
Paramus, United States Scimaxconsulting Full timeJoin 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...
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GCP Auditor/Senior
2 weeks ago
Paramus, NJ, United States Actalent Full timeJob Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's compliance directives. This position supports quality management systems to minimize risks in a regulated pharmaceutical environment....
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GCP Auditor/Senior
2 weeks ago
Paramus, NJ, United States Actalent Full timeJob Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's compliance directives. This position supports quality management systems to minimize risks in a regulated pharmaceutical environment....
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GCP Auditor/Senior
6 days ago
Paramus, NJ, United States Actalent Full timeJob Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's compliance directives. This position supports quality management systems to minimize risks in a regulated pharmaceutical environment....
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GCP Sr. Auditor Paramus, NJ unitedmstates
1 week ago
Paramus, NJ, United States ESR Healthcare Full timeAbout the job GCP Sr. Auditor Paramus, NJ unitedmstates Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No JOB DESCRIPTION: The GCP Quality Assurance...
