GCP Auditor - Clinical Trials Quality & Compliance

BioSpace; King of Prussia (PA); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

CSL Behring is seeking a GCP Auditor to execute the global audit plan, ensuring data integrity and compliance with legal and corporate standards. You will audit clinical sites, CROs, and internal trial processes to identify non-compliance trends and drive corrective actions for long-term system stability.

The role requires 3+ years in QA within a GCP framework, strong communication with multinational teams, and up-to-date knowledge of ICH E6(R3) and CFR guidelines.

Qualifikationen

• Academic background: BS degree in a relevant biological science, science, or related discipline.
• Professional experience: 3+ years of Quality Assurance experience within a GCP-regulated environment, demonstrating understanding of clinical trial phases, monitoring, and regulatory frameworks.
• Audit expertise: Experience in clinical audit and inspection management, with understanding of QA requirements in clinical research.
• Communication skills: Excellent interpersonal and negotiation skills for multinational teams.
• Working knowledge of: ICH E6 (R3) Guideline.
• Familiarity with 21 CFR Part 11, Part 50, Part 312, Part 812.
• Knowledge of CTR (EU) No 536/2014 and EC Directives relevant to GCP.
• Organizational agility: strong analytical and problem-solving skills; able to work with limited supervision; travel up to 50%.

Aufgaben

• Audit Execution: Conduct external audits of clinical investigator sites, CROs, E-System providers, and IRBs/ECs.
• Reporting & Risk Categorization: Develop Audit Reports; categorize findings by risk and provide CAPA recommendations.
• Trend Analysis: Identify non-compliance trends and systemic risks; communicate findings to management.
• Continuous Improvement: Assist in SOP improvements for audits and partner with stakeholders on risk-based, compliant solutions.
• Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations and industry trends.

Kenntnisse

GCP QA experience

Audit management

Regulatory knowledge

Communication skills

ICH E6(R3) knowledge

Travel readiness

Ausbildung

BS degree in biological sciences

Jobbeschreibung

CSL Behring is seeking a GCP Auditor to execute the global audit plan, ensuring data integrity and compliance with legal and corporate standards. You will audit clinical sites, CROs, and internal trial processes to identify non-compliance trends and drive corrective actions for long-term system stability.

The role requires 3+ years in QA within a GCP framework, strong communication with multinational teams, and up-to-date knowledge of ICH E6(R3) and CFR guidelines.