Auditor - GVP

CSL; King of Prussia (PA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

CSL Behring in King of Prussia is seeking an experienced GVP auditor to execute the global pharmacovigilance audit plan within our R&D Quality program. You will audit external partners and internal safety processes to ensure data integrity and regulatory compliance, driving CAPAs and continuous improvement across the safety organization.

You will analyze findings, categorize risk, and collaborate with cross-functional teams to implement corrective actions, with up to 50% travel supporting global

Qualifications

• Academic Background: BS degree in a relevant biological science, pharmacy, or related field.
• Professional Experience: QA in a GVP-regulated environment with drug safety operations understanding.
• Audit Expertise: Experience in audit and inspection management for quality assurance in pharmacovigilance.
• Communication Skills: Excellent interpersonal and negotiation skills with multinational teams.
• Working Knowledge: Familiarity with ICH E2D/E2A/E2B/E2C/E2F and EMA GVP modules plus 21 CFR parts.

Responsibilities

• Audit Execution: conduct external pharmacovigilance audits and internal self-inspections.
• Reporting & Risk Categorization: create audit reports and categorize findings with CAPA recommendations.
• Trend Analysis: identify non-compliance trends and systemic risks in PV.
• Continuous Improvement: help update SOPs and risk-based compliant solutions.
• Regulatory Knowledge: maintain up-to-date knowledge of global GVP regulations and industry trends.

Skills

Quality Assurance in GVP environment

Audit and inspection management

Communication skills

Education

BS degree in biological science, pharmacy, or related field

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 Guidelines 21 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 726/2004 Commission Implementing Regulation (EU) No 520/2012 EMA 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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

Inclusion and Belonging

You Belong at CSL. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.

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