Together We Talent
GCP Quality Assurance Auditor (Radiopharmaceuticals)
Together We Talent, Paramus, New Jersey, us, 07653
GCP Quality Assurance Auditor (Radiopharmaceuticals)
Paramus, NJ (Onsite) | Contract | Mid-Senior Level | 1 Opening
Hourly Rate: $60/hour | No Relocation Assistance | No Visa Sponsorship
Travel: Up to 10%
A growing biopharmaceutical organization is seeking a
GCP Quality Assurance Auditor
to support global
GXP compliance
across clinical development, safety/pharmacovigilance, and vendor oversight. This role is ideal for an experienced QA professional with deep
GCP expertise
and prior experience in
Radiopharmaceuticals .
This is a
100% onsite role
based in Paramus, NJ, supporting a regulated clinical environment.
Position Overview The GCP Quality Assurance Auditor will support the GCP/PVG Quality function by planning, executing, and managing
internal and external GXP audits . This role partners closely with Clinical Operations, Non-Clinical, Manufacturing, CROs, CMOs, investigator sites, and vendors to ensure compliance with global regulatory requirements and internal quality systems.
Key Responsibilities
Plan and conduct
global clinical process and vendor audits
across all clinical trials
Perform
risk-based audits
of clinical systems, processes, and vendors
Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC)
Develop, finalize, and distribute audit reports to key stakeholders
Own and manage
audit findings, CAPAs, and non-conformances
Audit compliance with
GCP, FDA regulations, ICH guidelines , and internal SOPs
Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight
Support regulatory agency inspections and inspection readiness activities
Contribute to continuous quality improvement initiatives
Requirements Key Responsibilities
Plan and conduct
global clinical process and vendor audits
across all clinical trials
Perform
risk-based audits
of clinical systems, processes, and vendors
Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC)
Develop, finalize, and distribute audit reports to key stakeholders
Own and manage
audit findings, CAPAs, and non-conformances
Audit compliance with
GCP, FDA regulations, ICH guidelines , and internal SOPs
Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight
Support regulatory agency inspections and inspection readiness activities
Contribute to continuous quality improvement initiatives
Required Qualifications
Bachelor’s degree in a
scientific, healthcare, or related discipline
5+ years of pharmaceutical industry experience
2+ years of experience in Radiopharmaceuticals
2+ years of Quality Assurance experience
Extensive hands‑on
GCP auditing experience
Proven experience conducting
internal and external GXP audits , including:
Clinical Development
Safety / Pharmacovigilance
Strong working knowledge of
FDA, EMA, ICH GCP , and global regulatory requirements
Experience auditing
clinical systems
such as IRT and EDC
Familiarity with
QMS, SOPs, and compliance documentation
Preferred Qualifications
Experience supporting
regulatory inspections
Exposure to global clinical teams and vendors
GCP or Quality Auditor certification (preferred, not required)
Work Requirements
Must be willing and able to work
100% onsite in Paramus, NJ
Monday–Friday onsite schedule
Up to
10% travel
#J-18808-Ljbffr
Hourly Rate: $60/hour | No Relocation Assistance | No Visa Sponsorship
Travel: Up to 10%
A growing biopharmaceutical organization is seeking a
GCP Quality Assurance Auditor
to support global
GXP compliance
across clinical development, safety/pharmacovigilance, and vendor oversight. This role is ideal for an experienced QA professional with deep
GCP expertise
and prior experience in
Radiopharmaceuticals .
This is a
100% onsite role
based in Paramus, NJ, supporting a regulated clinical environment.
Position Overview The GCP Quality Assurance Auditor will support the GCP/PVG Quality function by planning, executing, and managing
internal and external GXP audits . This role partners closely with Clinical Operations, Non-Clinical, Manufacturing, CROs, CMOs, investigator sites, and vendors to ensure compliance with global regulatory requirements and internal quality systems.
Key Responsibilities
Plan and conduct
global clinical process and vendor audits
across all clinical trials
Perform
risk-based audits
of clinical systems, processes, and vendors
Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC)
Develop, finalize, and distribute audit reports to key stakeholders
Own and manage
audit findings, CAPAs, and non-conformances
Audit compliance with
GCP, FDA regulations, ICH guidelines , and internal SOPs
Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight
Support regulatory agency inspections and inspection readiness activities
Contribute to continuous quality improvement initiatives
Requirements Key Responsibilities
Plan and conduct
global clinical process and vendor audits
across all clinical trials
Perform
risk-based audits
of clinical systems, processes, and vendors
Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC)
Develop, finalize, and distribute audit reports to key stakeholders
Own and manage
audit findings, CAPAs, and non-conformances
Audit compliance with
GCP, FDA regulations, ICH guidelines , and internal SOPs
Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight
Support regulatory agency inspections and inspection readiness activities
Contribute to continuous quality improvement initiatives
Required Qualifications
Bachelor’s degree in a
scientific, healthcare, or related discipline
5+ years of pharmaceutical industry experience
2+ years of experience in Radiopharmaceuticals
2+ years of Quality Assurance experience
Extensive hands‑on
GCP auditing experience
Proven experience conducting
internal and external GXP audits , including:
Clinical Development
Safety / Pharmacovigilance
Strong working knowledge of
FDA, EMA, ICH GCP , and global regulatory requirements
Experience auditing
clinical systems
such as IRT and EDC
Familiarity with
QMS, SOPs, and compliance documentation
Preferred Qualifications
Experience supporting
regulatory inspections
Exposure to global clinical teams and vendors
GCP or Quality Auditor certification (preferred, not required)
Work Requirements
Must be willing and able to work
100% onsite in Paramus, NJ
Monday–Friday onsite schedule
Up to
10% travel
#J-18808-Ljbffr