At a Glance
- Tasks: Conduct audits to ensure compliance and improve quality in global supply chains.
- Company: Join CSL Seqirus, a leading influenza vaccine provider with a commitment to innovation.
- Benefits: Enjoy competitive benefits, including health support and a focus on well-being.
- Other info: Dynamic role with travel opportunities and a culture of inclusion and belonging.
- Why this job: Make a real impact on global health by ensuring product quality and safety.
- Qualifications: BS degree in biological science and experience in GMP-regulated environments required.
The predicted salary is between 55000 - 65000 £ per year.
Quality in a globalized supply chain is a matter of operational resilience as much as regulatory mandate. This role serves as a GMP 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 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.
Global GMP Auditor: Compliance & CAPA Leader in Maidenhead employer: CSL
CSL Seqirus is an exceptional employer, offering a dynamic work environment that prioritises quality and compliance in the global healthcare landscape. With a strong commitment to employee growth, inclusive culture, and innovative practices, team members are empowered to make meaningful contributions while enjoying comprehensive benefits and opportunities for professional development. Located in key production hubs, employees benefit from collaboration with multinational teams and the chance to impact public health on a global scale.
StudySmarter Expert Advice🤫
We think this is how you could land Global GMP Auditor: Compliance & CAPA Leader in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to professionals in the GMP and quality assurance fields on LinkedIn. Join relevant groups and participate in discussions to get your name out there and show off your expertise.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global GMP regulations and industry trends. Be ready to discuss how you've tackled compliance issues in the past and how you can bring that experience to CSL Seqirus.
✨Tip Number 3
Showcase your audit expertise! Bring examples of your previous audit reports and findings to the interview. This will demonstrate your analytical skills and your ability to communicate complex information effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining the CSL Seqirus team.
We think you need these skills to ace Global GMP Auditor: Compliance & CAPA Leader in Maidenhead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in GMP auditing and quality assurance. Use keywords from the job description to show that you understand what we're looking for.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your audit experience and how you've contributed to compliance and CAPA initiatives in the past.
Showcase Your Regulatory Knowledge:Since this role requires up-to-date knowledge of global GMP regulations, make sure to mention any relevant certifications or training you've completed. This will demonstrate your commitment to maintaining high-quality standards.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don't miss out on any important updates!
How to prepare for a job interview at CSL
✨Know Your GMP Regulations
Brush up on the latest global GMP regulations and industry trends. Being well-versed in 21 CFR Part 210/211, EudraLex Volume 4, and other relevant guidelines will show that you’re not just familiar with the rules but also committed to maintaining high-quality standards.
✨Prepare for Audit Scenarios
Think through potential audit scenarios you might face in the role. Prepare examples from your past experiences where you identified non-compliance trends or developed corrective actions. This will demonstrate your practical knowledge and problem-solving skills.
✨Showcase Your Communication Skills
Since this role involves working with multinational teams and external suppliers, practice articulating your thoughts clearly. Be ready to discuss how you've effectively communicated findings and recommendations in previous roles, as strong interpersonal skills are key.
✨Emphasise Continuous Improvement
Be prepared to discuss how you’ve contributed to improving standard operating procedures (SOPs) in your past positions. Highlight any initiatives you’ve led or been part of that focused on compliance and risk management, showcasing your proactive approach to quality assurance.
