GCP Senior AuditorScimaxconsulting • Paramus, NJ, US
GCP Senior Auditor
Scimaxconsulting • Paramus, NJ, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionDevelop 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. 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 in auditing clinical systems such as IRT and EDC. Experience within a biopharmaceutical organization focused on neurology or psychiatry therapeutic areas. Strong communication and stakeholder engagement skills. Hybrid schedule : 3 days on-site (Tuesday-Thursday) in Paramus, NJ. Flexibility is required as the on-site schedule may adjust over time. Up to 10% travel may be required for audits and inspections.
Job Description
Job Description
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
Required Qualifications
Preferred Qualifications
Additional Details
serp_jobs.job_alerts.create_a_job
Senior Auditor • Paramus, NJ, US
Job_description.internal_linking.related_jobs
Employment Type (Portal Display).Company's global internal audit activities.Company policies, the Internal Audit Charter and the Institute of Internal Auditors' ("IIA") International Standards for ...serp_jobs.internal_linking.show_more
Focus on the core content of the job post, removing all extra metadata, navigation, and redundant headers.Keep the formatting beautiful and high signal to noise ratio.serp_jobs.internal_linking.show_more
Position Summary : Under the direction of the Executive Deputy Inspector General for Audit (EDIG / Audit), the Senior Auditor / Analyst is responsible, within the mandate of the MTA Inspector General, f...serp_jobs.internal_linking.show_more
Location - 405 Lexington, New York, NY.We are currently looking for a Senior Internal Auditor with SOX 404 experience to support our Internal Audit team.
The job will include IT audit as well as.Del...serp_jobs.internal_linking.show_more
The New York City Department of Investigation (DOI) is one of the oldest law enforcement agencies in the country with a mission of combating municipal corruption.
It serves the people of New York Ci...serp_jobs.internal_linking.show_more)
At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibil...serp_jobs.internal_linking.show_more
Job Title : Manager Auditor Public firm.Location : Bergen County, NJ or Westchester County NY.The ideal candidate is a CPA with the.
This is a hands-on role for a dependable and detail-oriented profes...serp_jobs.internal_linking.show_more
Have you ever had that green-light feeling? When you hit every green light and the day just feels like magic.CLEAR's mission is to create frictionless experiences where every day has that feeling.W...serp_jobs.internal_linking.show_more
Join a newly formed team supporting both treaty operations and a recently launched function at a leading global reinsurer.
This role is focused on financial oversight of reinsurance contracts, ensur...serp_jobs.internal_linking.show_more
A company is looking for a Senior Internal Auditor to join their Internal Audit team.Key Responsibilities Lead operational, financial, IT, compliance, and strategic control assessments Utilize f...serp_jobs.internal_linking.show_more
Here at Avis Budget Group, you will be part of a global team of 25,000 driven individuals united by a shared purpose : to shape the future of mobility through innovative, customer-focused solutions....serp_jobs.internal_linking.show_more
Principal Auditor (Experienced Senior Auditor) Corporate Compliance Audits (Hybrid).Capital One's Audit function is a dedicated group of professionals focused on delivering top-quality assurance se...serp_jobs.internal_linking.show_more Senior Account Control Auditor.The Finance Office is recruiting to fill one (1) Management Auditor II Auditor to function as a Senior Account Auditor who will : .
Perform both Annual and Final closeou...serp_jobs.internal_linking.show_more 
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 the...serp_jobs.internal_linking.show_more
At Prudential, we believe talent is key to achieving our vision.When you join Prudential, you'll unlock a motivating and impactful career all while growing your skills and advancing your professio...serp_jobs.internal_linking.show_more
If you are a proven and experienced Audit Senior looking to contribute your expertise to a top CPA firm, an exceptional opportunity awaits! This respected and expanding CPA firm is seeking an Audit...serp_jobs.internal_linking.show_more
The New York City Department of Investigation (DOI) is one of the oldest law enforcement agencies in the country; its mission is to combat municipal corruption.
DOI serves the people of New York Cit...serp_jobs.internal_linking.show_more
Mercury is building a complete finance stack for startups.We work hard to create the easiest and safest banking experience possible to simplify entrepreneurs' and business owners' financial lives.T...serp_jobs.internal_linking.show_more
Senior Internal Auditor
Atlas Air • White Plains, NY, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
AVP, Senior Lead Auditor
SCOR • New York, NY, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Auditor / Analyst
StateJobsNY • New York, NY, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Auditor
The Rockridge Group • New York, NY, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Investigative Auditor
City of New York • New York, NY, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
PwC Private - Audit Senior Associate
PwC (US) • New York, NY, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Auditor Public Firm
Donna Cornell Enterprises, Inc. • Bergen County, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Internal Auditor
CLEAR • New York, NY, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Internal Auditor
Vaco by Highspring • White Plains, CT, US
serp_jobs.job_card.permanent
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Internal Auditor
VirtualVocations • Paterson, New Jersey, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Auditor
Avis Budget Group • Parsippany, NJ, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Principal Auditor (Experienced Senior Auditor) Corporate Compliance Audits (Hybrid)
Capital One • New York, NY, US
serp_jobs.job_card.full_time +1
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
SENIOR ACCOUNT CONTROL AUDITOR
City of New York • New York, NY, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
GCP Senior Auditor
Together We Talent • Paramus, NJ, us
serp_jobs.job_card.full_time
serp_jobs.filters_job_card.quick_apply
serp_jobs.last_updated.last_updated_variable_days
Senior Auditor
Prudential Financial • Newark, NJ, US
serp_jobs.job_card.part_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Audit Senior
GPAC • Stamford, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Investigative Auditor
New York City Department of Investigation • Manhattan, NY, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Senior Internal Auditor
Mercury • New York, NY, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted