HireReady Partners ยท 1 day ago
GCP Quality Assurance Auditor
Paramus, NJ
Full-time
Onsite
Senior Level
5+ years expHireReady Partners is assisting a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies in their search for a GCP Quality Assurance Auditor. This role focuses on ensuring GXP compliance with regulatory authorities and involves conducting various audits to support clinical trials and manage related vendor relationships.
Information Technology & Services
Responsibilities
Plan 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 along with various SMEs (IRT, EDC etc.) to comprehensively 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 (e.g. FDA regs, GCP, etc.)
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
Qualification
Required
5+ years of pharmaceutical experience
2+ years of RadioPharmaceutical and Quality Assurance experience
BS degree in scientific, health care or related discipline
Intensive 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
10% Traveling required
Company
HireReady Partners
We're passionate about helping businesses thrive through connecting them with top talent.
0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase