GVP Auditor: Pharmacovigilance Quality & Compliance

CSL Plasma; Waltham (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

CSL Plasma in Massachusetts is seeking a GVP Auditor to join the Research & Development Quality audit program. You will execute the global audit plan, audit pharmacovigilance vendors and internal safety processes, and help safeguard the reliability of the PV systems.

The role demands strong audit management, cross-functional collaboration with LSOs/RSOs, and the ability to translate findings into CAPA actions that strengthen compliance with EMA GVP Modules and U.S. regulations.

Qualifications

• Academic Background: BS degree in a relevant biological science, pharmacy, or related discipline.
• Professional Experience: Quality Assurance experience within a GVP-regulated environment, with a strong understanding of drug safety operations and regulatory frameworks.
• Audit Expertise: Experience in audit and inspection management within pharmacovigilance.
• Communication Skills: Excellent interpersonal and negotiation skills for multinational stakeholders.
• Working Knowledge: Working knowledge of ICH GVP guidelines and EMA GVP Modules and global regulations.

Responsibilities

• Audit Execution: Conduct external audits of pharmacovigilance vendors and internal safety processes and self-inspections.
• Reporting & Risk Categorization: Prepare audit reports and categorize findings with CAPA recommendations.
• Trend Analysis: Identify non-compliance trends and systemic risks within PV and communicate findings to management.
• Continuous Improvement: Help update SOPs and implement risk-based, compliant solutions.
• Regulatory Knowledge: Maintain up-to-date knowledge of global GVP regulations and EMA guidelines.

Skills

Audit experience

Communication skills

Analytical thinking

Organizational agility

Education

BS degree in a relevant biological science, pharmacy, or related discipline

Job description

CSL Plasma in Massachusetts is seeking a GVP Auditor to join the Research & Development Quality audit program. You will execute the global audit plan, audit pharmacovigilance vendors and internal safety processes, and help safeguard the reliability of the PV systems.

The role demands strong audit management, cross-functional collaboration with LSOs/RSOs, and the ability to translate findings into CAPA actions that strengthen compliance with EMA GVP Modules and U.S. regulations.