GCP Auditor, Quality Assurance

Katalyst Healthcares and Life Sciences

Hackensack, NJ

Job Description:

The GCP Quality Assurance Auditor reports to the Director of GCP/PVG Quality Assurance and is responsible for ensuring GxP compliance with regulatory authorities. The role focuses on implementing compliance directives, supporting quality management systems, and minimizing risk in a regulated pharmaceutical environment.
The auditor conducts and participates in internal and external GxP audits, supporting Clinical Operations, Non-Clinical, Manufacturing, and Pharmacovigilance activities. The position works closely with CROs, CMOs, investigator sites, vendors, and cross-functional teams to support clinical trials.
This opportunity is with a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies.

Responsibilities:

Plan and conduct global clinical process and vendor audits across clinical trials.
Perform risk-based audits of specific clinical processes.
Conduct clinical vendor audits with SMEs (e.g., IRT, EDC).
Develop and distribute audit reports to stakeholders.
Own and manage clinical vendor non-conformances (CAPAs).
Review and audit compliance with FDA regulations, ICH-GCP, and related guidelines.
Collaborate with clinical sourcing, supplier quality, and clinical partnerships.
Support regulatory agency inspections.
Participate in quality improvement initiatives.

Job Requirements / Qualifications:

2+ years of pharmaceutical industry experience.
Bachelor's degree in scientific, healthcare, or related discipline.
Strong GCP and safety background.
Experience with internal and external audits (process & systems).
Strong knowledge of SOPs, QMS, policies, and procedures.
bility to work with global clinical teams.
10% travel required.

Ideal Candidate Profile:

Extensive GCP auditing experience.
Strong communication skills with internal teams and external partners.
Detail-oriented with a risk-based auditing mindset.

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the GCP Auditor, Quality Assurance in Hackensack, NJ vacancy

GCP Sr. Auditor
...GCP Sr. Auditor Paramus, New Jersey, United States About the Job GCP Sr. Auditor The GCP Quality Assurance Sr. Auditor will report to the Director of GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities...
Suggested
5 Star Global Recruitment Partners
Paramus, NJ
4 days ago
Senior GCP Auditor (Good Clinical Practice Quality Assurance)
...implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated... ...industry The ideal candidate will have extensive GCP experience. Proven experience conducting and managing internal...
Suggested
3 days per week
Macpower Digital Assets Edge
Paramus, NJ
14 hours ago
GCP Senior Auditor
...Job Description GCP Senior Auditor Paramus, NJ (Hybrid) Contract Mid-Senior Level Ensure GxP compliance, quality oversight, and audit excellence for a fast-growing biopharmaceutical... ...Senior Auditor to support Quality Assurance programs across global clinical...
Suggested
Contract work
Together We Talent
Paramus, NJ
7 hours ago
GCP Auditor
...conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and...
Suggested
Katalyst HealthCares & Life Sciences
Paramus, NJ
13 hours ago
GMP Senior Auditor
...Radiopharmaceuticals Quality Assurance Auditor The Radiopharmaceuticals Quality Assurance Auditor is responsible for planning, conducting, and... ...Certifications: ~ ASQ Certified Quality Auditor (CQA). ~ ISO 9001 Lead Auditor. ~ GCP/GMP auditing certifications....
Suggested
Katalyst HealthCares & Life Sciences
Paramus, NJ
12 hours ago
Sr. Auditor
...About the job Sr. Auditor Sr. Auditor Quality Assurance (Pharmaceuticals) Location: Paramus, NJ (100% On-Site) - 5 month contract Experience... ...(CQA) • ISO 9001 Lead Auditor Certification • GCP/GMP Auditing Certifications Why You Should Apply...
Hourly pay
Contract work
Relocation package
Global Placement Firm
Paramus, NJ
14 hours ago
GMP Sr. Auditor Paramus, NJ
...GMP Sr. Auditor Paramus, NJ GMP Sr. Auditor Paramus, NJ Experience level: Mid-senior... ...cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical... ...Auditor (CQA) ISO 9001 Lead Auditor GCP/GMP auditing certifications Working...
Hourly pay
Visa sponsorship
Relocation package
ESR Healthcare
Paramus, NJ
4 days ago
Professional Coding Auditor FT Days
$30 per hour
...Professional Coding Auditor FT Days Req Id: 64915 Englewood Health, a leading healthcare system comprising Englewood Hospital and the Englewood Health Physician Network, is committed to delivering exceptional patient care across northern New Jersey. We...
Full time
Work at office
Shift work
Englewood Health
Englewood, NJ
3 days ago
Tech Senior Auditor - Commercial & Investment Banking
...from planning to reporting, and produce quality deliverables to both department and professional... ...compliance, fraud prevention), external auditors, and regulators, establishing strong... ...knowledge in public cloud provider (AWS, GCP, Azure) services To be eligible for...
Visa sponsorship
Flexible hours
Chase
Jersey City, NJ
10 hours ago
QA Audits & Controls Manager
$90k - $120k
...Partner with Ops and Vendor Performance on remediation plans. Support risk, compliance, and investor reviews. Produce reporting on quality trends and control effectiveness. REQUIRED QUALIFICATIONS Bachelor's degree in business, operations, or related fields....
Work at office
Remote work
Q-Cells
Teaneck, NJ
2 days ago
Freelance Online Casino Auditor (Hiring Immediately)
$1,000 per month
Join Our Team as a Website Tester at Little Wheel Little Wheel is a gambling technology company focused on researching and building products that put players first. We are currently hiring Website Testers across Michigan, New Jersey, Pennsylvania, and West Virginia...
Extra income
Temporary work
Freelance
Second job
Currently hiring
Immediate start
Work from home
Flexible hours
Little Wheel
Kearny, NJ
5 days ago
Program Integrity Auditor
$46.99k - $122.4k
...purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger -... ...community at a time. Position Summary The Program Integrity Auditor is responsible for the review of records for medical,...
Hourly pay
Full time
Temporary work
Local area
Monday to Friday
Flexible hours
CVS Health
Rutherford, NJ
4 days ago
Sr. Auditor (Hybrid - Secaucus, NJ)
$96k - $120k
...* and so much more! We're looking for a driven Sr. Internal Auditor to join our collaborative internal audit team, not just to review... ...the audit scope (working with the audit manager), oversee the quality of the product, supervise team members, and serve as a liaison...
Full time
Part time
Work at office
Flexible hours
Quest Diagnostics Incorporated
Secaucus, NJ
2 days ago
Auditor II
...Position: Auditor II Location: Jersey City, NJ 07310 Duration: 3+Month contract Responsibilities Participating in... ...Performing in-depth reviews of individual credits to assess credit quality and validate the accuracy of the assigned counterparty risk...
Contract work
Work experience placement
Bank staff
Ageatia Global Solutions
Jersey City, NJ
4 days ago
Senior Auditor
...-based audits from planning through reporting, delivering high-quality work within established timelines and budgets. The individual partners... ...is on time and within the allocated budget, notifying the lead auditor promptly of any issues that arise or when budgets or timelines...
Remote work
Flexible hours
Dtcc
Jersey City, NJ
3 days ago
Senior Auditor - Consumer & Community Banking Connected Commerce
...Senior Auditor Associate Use your judgement to strength JPMorganChase's internal controls! As a Senior Auditor Associate in our Internal Audit group, you will plan, execute and document audit reports, partner closely with global Audit colleagues and business stakeholders...
Flexible hours
Chase
Jersey City, NJ
14 hours ago
Auditor III
...steward will lead the business line stream, supporting Finance & Tax teams by analyzing data issues, investigating anomalies from data quality checks, and proposing and implementing data sourcing structures. This includes: # Elicit, analyze, and document business...
Work at office
Ageatia Global Solutions
Jersey City, NJ
3 days ago
Compliance Medical Records Auditor
$63k - $87k
...Compliance Medical Records Auditor Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise... ...will be joining a dedicated team of professionals who deliver quality, value, and access in the 21st century and align all...
Immediate start
RadNet
Passaic, NJ
10 hours ago
Auditor II
Credit Analyst Position Candidates must have: Extensive credit analysis experience covering large corporate and/or financial institutions (this would likely include experience at a large US or international bank or at a rating agency) o Please exclude candidates...
Infotree Global Solutions
Jersey City, NJ
10 hours ago
DTCC - IT Internal Audit Manager
...Internal Audit Manager position has direct oversight of the quality assurance work being conducted by their team, with a focus on assessing... ...system resiliency. Responsibilities can include acting as the Auditor-in-Charge on more complex reviews. Audit Managers have supervisory...
Beyond SOF
Jersey City, NJ
1 day ago
Senior Vice President, Auditor, Credit Risk
$102k - $203k
...Senior Vice President, Auditor, Credit Risk At BNY, our culture allows us to run our company better and enables employees' growth... ...Regulation Letters (e.g. SR 11-10) Experience drafting high-quality audit issues (issue articulation, impact, root cause, action plans...
Temporary work
Work at office
Worldwide
Flexible hours
BNY
Jersey City, NJ
14 hours ago
Lead Auditor
...Job Title – Lead Auditor Location - Franklin Lakes, NJ Duration – 4+ Months Work hours: 8am-5pm, 40 hours/week Client: Medical... ...our medical device DHF for compliance with respect to internal Quality Systems and other relevant standards, specifically ISO 13485,...
Full time
Contract work
Work experience placement
Work from home
MILLENNIUMSOFT
Franklin Lakes, NJ
4 days ago
Project Employee, Stats Auditor
$25 per hour
Project Employee This is a temporary position with an expected duration not to exceed (10) months. This job posting is for candidate pipeline purposes and is not an active hiring opportunity. By submitting your application, you are expressing interest in potential future...
Temporary work
Local area
Night shift
NBA
Secaucus, NJ
1 hour ago
Vice President, Operational Risk Auditor
$188.18k - $195k
...BNP Paribas RCC Inc. Job Title: Vice President, Operational Risk Auditor Location: 525 Washington Boulevard, Jersey City, NJ 07310 Duties:Support the internal audit team to independently assess the effectiveness of the operational risk management framework, including...
Work at office
Remote work
Monday to Friday
BNP Paribas
Jersey City, NJ
4 days ago
IT Auditor
$62k - $90k
...direct supervision of the Manager of IT Audit, the IT Auditor will be responsible for providing high-quality internal audits that ensure procedural and... ...a value-added resource in designing and executing assurance responsibilities to help the organization achieve its...
H1b
Work at office
Visa sponsorship
Flexible hours
BetMGM
Passaic, NJ
1 day ago
Vice President, Auditor, Clearance and Collateral Management
$68k - $160k
...Vice President, Auditor, Clearance and Collateral Management At BNY, our culture allows us to run our company better and enables employees' growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly...
Temporary work
Worldwide
Flexible hours
BNY
Jersey City, NJ
1 day ago
Vice President, Auditor, Global Payments and Trade/Treasury Services
$68k - $160k
...Vice President, Auditor, Markets and Wealth Services At BNY, our culture allows us to run our company better and enables employees' growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20...
Temporary work
Work experience placement
Worldwide
Flexible hours
BNY
Jersey City, NJ
1 day ago
Outpatient Coding Auditor (HIM), Full Time, Day, Remote
$33.99 - $42.49 per hour
...Outpatient Coding Auditor The Outpatient Coding Auditor is responsible for auditing coded outpatient medical records to ensure compliance... ...becoming part of a dedicated team that values the highest quality of care in a supportive environment. In our commitment to high...
Remote job
Hourly pay
Full time
Temporary work
Part time
Local area
Flexible hours
Shift work
Valley Health System (New Jersey)
Ridgewood, NJ
4 days ago
IT Auditor II
...About the job IT Auditor II Our employees work at the center of the worlds financial markets, bringing both innovation and stability... ...demonstrates a strong understanding of audit techniques. Quality Process Demonstrates a validated understanding of our policies...
Full time
Work at office
Flexible hours
MyHR Rescue
Jersey City, NJ
2 days ago
IT Audit Manager
...for running audit projects and is commonly referred to as the Auditor In-Charge. IT Audit Managers also manage people on audit projects... ...monitoring tests and coordinate the development of new test Quality Process Demonstrate strong compliance with our policies &...
Remote work
Flexible hours
Dtcc
Jersey City, NJ
2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to GCP Auditor, Quality Assurance. Be the first to apply!