What are the responsibilities and job description for the Senior Auditor, GCP Quality Assurance position at SSi People?
Job Title: Senior Auditor, GCP Quality Assurance
Location: Paramus, NJ (Hybrid)
Job Summary
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
Location: Paramus, NJ (Hybrid)
Job Summary
- Are you a seasoned auditor with a strong background in GCP and safety? We have an exciting opportunity for you! Our client, a rapidly expanding biopharmaceutical company specializing in Neurology and Psychiatry therapies, is seeking a Senior Auditor for their GCP Quality Assurance team. This role requires on-site presence and offers a hybrid work model for flexibility.
- Conduct global clinical process and vendor audits across all clinical trials.
- Plan and execute audits of specific clinical processes based on risk.
- Perform comprehensive assessments of services provided by clinical vendors.
- Develop and distribute audit reports to relevant stakeholders.
- Manage related clinical vendor non-conformances.
- Support the preparation and coordination of regulatory agency inspections.
- Minimum of 5 years of experience in the pharmaceutical industry.
- Bachelor’s degree in a scientific, healthcare, or related discipline.
- Extensive 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.
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
