Auditor GMP

Quality in a globalized supply chain is a matter of operational resilience as much as regulatory mandate. This role serves as a GMP Auditorwithin our Research & Development Quality audit program responsible for executing the global audit plan to ensure the accuracy of scientific data and compliance with legal and corporate standards. By conducting audits of our external partners and internal facilities you identify the findings and non-compliance trends that could impact the reliability of our product supply. We are looking for an experienced auditor who can navigate manufacturing 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 contract manufacturers (CMOs) vendors and suppliers as well as occasional internal self-inspections of manufacturing processes and procedures.
• Reporting & Risk Categorization:Develop and issue comprehensive Audit Reports categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA).
• Trend Analysis:Identify non-compliance trends and systematic risks within the GMP discipline communicating these findings to line management and functional leads.
• Continuous Improvement:Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based compliant solutions.
• Regulatory Knowledge:Maintain up-to-date knowledge of global GMP regulations and industry trends identifying new requirements to ensure a high level of quality is maintained internally.

Position Qualifications & Experience

• Academic Background:BS degree in a relevant biological science science or related discipline.
• Professional Experience:Quality Assurance experience within a GMP-regulated environment demonstrating a strong understanding of quality management systems and regulatory frameworks.
• Audit Expertise:Experience in audit and inspection management with a clear understanding of the requirements for quality assurance in the manufacturing discipline.
• Communication Skills:Excellent interpersonal and negotiation skills with the ability to work effectively with multinational teams and external suppliers.
• Working knowledge of:

21 CFR Part 210/211 Current Good Manufacturing Practice for drugs

21 CFR Part 600 Biological products

21 CFR Part 820(ISO 13485)

EudraLex Volume 4 EU GMP Guidelines

Directive 2001/83/EC

• 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 Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis 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.

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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.

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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 our On the Front Line video to learn more about CSL Seqirus