GCP Quality Assurance Auditor (Radiopharmaceuticals)
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Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
GCP Quality Assurance Auditor (Radiopharmaceuticals)
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
Bachelors 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
MondayFriday onsite schedule
Up to 10% travel
Required Skills:
5 years of pharmaceutical experience 2 years of RadioPharmaceutical and Quality Assurance experienceIntensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies procedures and standards (SOPs QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies
Required Education:
BS degree in scientific health care or related discipline
Company Industry
IT Services and IT Consulting
Key Skills
- Laboratory Experience
- Quality Assurance
- FDA Regulations
- ISO 9001
- Quality Audits
- Quality Management
- GLP
- cGMP
- EPA
- QA/QC
- Toxicology Experience
- Aviation Experience
