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,…
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Full-time
bachelor degree
Posted 42d ago
~40 hrs/week
Responsibilities
Execute global audit plans for internal safety functions and external pharmacovigilance vendors to ensure data accuracy and regulatory compliance. Identify non-compliance trends and collaborate with stakeholders to implement corrective and preventive actions (CAPA).
Requirements
Requires a BS degree in biological science, pharmacy, or a related field with professional Quality Assurance experience in a GVP-regulated environment. Must possess strong knowledge of global GVP regulations, ICH guidelines, and be able to travel up to 50%.
Full 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.
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.
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.
Related keywords
GVPPharmacovigilanceDrug SafetyEMA GuidelinesICH E2DICH E2AICH E2BICH E2CICH E2F21 CFR Part 314.8021 CFR Part 60021 CFR Part 4Directive 2001/83/ECRegulation (EC) No 726/2004PSMFCAPA
CSL is a leading global biopharma company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.
Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 29,000+ people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.
See our community guidelines: https://bit.ly/3Bs17Ra
Offices: 655 Elizabeth St, Melbourne, Victoria 3000, AU · 1020 1st Ave, King of Prussia, PA 19406, US
Complex biologicalsvaccinesplasma and plasma derived therapeuticsbiotechnologyand biopharmaHealth DiagnosticsHealth CareBiotechnologyMedical
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