Quality in a globalized supply chain is a matter of operational resilience as much as regulatory mandate. This role serves as aGMP Auditor within 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 to50% travel.
About CSL Seqirus
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
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