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.
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. And Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
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.
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.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus