RemoteHybrid GCP Sr Auditor

Work Staff; Paramus (NJ); Hybrid; USD 80,000 - 110,000; Full time

Job summary

A leading staffing agency is seeking a Remote/Hybrid GCP Sr. Auditor to ensure compliance in a regulated pharmaceutical environment. This role involves conducting audits, supporting quality management systems, and collaborating with cross-functional teams. Ideal candidates will have extensive experience in GCP and safety, along with a solid background in pharmaceutical audits. Join a dynamic team where your expertise will help shape quality assurance processes and drive success in clinical development. Embrace the opportunity to make a significant impact while working remotely or in a hybrid setting.

Qualifications

• 5+ years of pharmaceutical experience required.
• Extensive GCP and safety background essential.

Responsibilities

• Ensure GXP compliance with regulatory authorities.
• Conduct internal and external GXP QA audits.

Skills

GCP Sr. Auditor

GCP

Auditor

Pharmaceutical

Audits

SOPs

QMS

GXP QA audit programs

GXP Compliance

Clinical Vendor Audits

Education

Bachelor's degree in scientific, healthcare, or related discipline

Job description

PostJobMatches By WorkStaff USA

PostJobMatches By WorkStaff USA is a leading staffing agency in the job placement industry, providing top-notch professionals to facilities across the country. Our team of experienced recruiters work together to match the best candidates with the right job and/or business opportunities.

Today we are hiring a Remote/Hybrid GCP Sr. Auditor for our client in Paramus, NJ.

Skills required on resume include: GCP Sr. Auditor, GCP, Auditor, Pharmaceutical, Audits, SOPs, QMS, GXP QA audit programs, GXP Compliance, GXP, Clinical Vendor Audits, SMEs (IRT, EDC etc.), FDA regs, Regulations, Bio-pharmaceutical, Safety Pharma-covigilance, Clinical Development.

Responsibilities

• Report to the Director of GCP/PVG Quality Assurance. Focus on ensuring GXP compliance with regulatory authorities, supporting quality management systems, and minimizing risk in a regulated pharmaceutical environment.
• Conduct and participate in GXP QA audit programs, including internal and external audits.
• Support clinical operations, non-clinical, and manufacturing teams to manage CROs, CMOs, investigator sites, and vendors supporting clinical trials.
• Collaborate with QA and cross-functional teams, communicate with QA consultants, and liaise with external auditees, vendors, partners, and affiliates.
• Perform and manage audits related to Clinical Development and Safety Pharmacovigilance.

Qualifications

• 5+ years of pharmaceutical experience
• Bachelor's degree in scientific, healthcare, or related discipline
• Extensive GCP and safety background
• Experience with internal and external process and systems audits
• Strong knowledge of development policies, SOPs, and QMS
• Ability to work with global clinical teams and develop audit objectives
• Willingness to travel up to 10%