Auditor - GVP

CSL Plasma; Waltham (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

CSL Plasma seeks an experienced GVP Auditor to execute the global audit plan for pharmacovigilance safety data. You will audit external vendors, internal safety processes, and affiliates, reporting findings and driving CAPAs to enhance PV system reliability.

Applicants should have a BS in a relevant field and QA experience in a GVP-regulated environment, with strong communication skills and willingness to travel up to 50%.

Qualifications

• Academic background in biological science, pharmacy or related field.
• 5+ years in QA within a GVP-regulated environment.
• Experience in audit and inspection management for pharmacovigilance.
• Excellent interpersonal and negotiation skills with multinational teams.
• Strong knowledge of ICH E2D, E2A, E2B, E2C, E2F and EMA GVP modules; willing to travel up to 50%.

Responsibilities

• Audit execution of external PV vendors and internal safety processes.
• Develop and issue Audit Reports with risk ratings and CAPA recommendations.
• Identify non-compliance trends to support PV system health.
• Support SOP improvements and risk-based compliant solutions.
• Maintain up-to-date knowledge of global GVP regulations and industry trends.

Skills

Quality Assurance

Audit management

Communication skills

Analytical thinking

Travel readiness

Education

BS degree in biological sciences/pharmacy

Job description

The Opportunity: Quality in a globalized drug safety network is a matter of operational resilience as much as regulatory mandate. This role serves as a GVP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of safety data and compliance with legal and corporate standards. By conducting audits of our external partners and internal safety functions, you identify the findings and non-compliance trends that could impact the reliability of our pharmacovigilance system. We are looking for an experienced auditor who can navigate complex safety environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.

Main Responsibilities

• Audit Execution: Conduct assigned external audits of pharmacovigilance vendors and service providers, as well as internal self-inspections of safety processes, systems, and affiliates (including Local/Regional Safety Officers (LSO/RSOs) activities).
• Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to drug safety.
• Trend Analysis: Identify non-compliance trends and systematic risks within the PV discipline, communicating these findings to line management and functional leads to support PV system health and protect the integrity of the PSMF documenting it.
• Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions that ensure compliance with EMA Guidelines on Good Pharmacovigilance Practices (GVP Modules), and applicable global and local regulatory requirements.
• Regulatory Knowledge: Maintain up-to-date knowledge of global GVP regulations (Good Pharmacovigilance Practices) and industry trends, to support internal quality and compliance.

Position Qualifications & Experience

• Academic Background: BS degree in a relevant biological science, pharmacy, or related science discipline.
• Professional Experience: Quality Assurance experience within a GVP-regulated environment, demonstrating a strong understanding of drug safety operations and regulatory frameworks.
• Audit Expertise: Experience in audit and inspection management, with a clear understanding of the requirements for quality assurance in the pharmacovigilance discipline.
• Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational teams and external stakeholders across different regions.
• Working Knowledge of: ICH E2D(R1), E2A, E2B(R3), E2C(R2), and E2F Guidelines21 CFR Part 314.80 (for drugs), 21 CFR Part 600 Subpart D (for biologics) and 21 CFR Part 4 (Combination product/duplicate reporting prevention)Directive 2001/83/EC (as amended)Regulation (EC) No 726/2004Commission Implementing Regulation (EU) No 520/2012EMA GVP Modules (I-XVI + product/population-specific modules)
• Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.