Site Lead Auditor, Associate Director - Dundalk Hybrid
Our company is seeking a dedicated and experienced Site Lead Auditor, Associate Director to join our team at the Dundalk facility, reporting to the Site Quality Head. This facility is committed to formulating and filling vaccine products that improve and transform lives globally. As a Site Lead Auditor, Associate Director, you will play a crucial role in ensuring our processes conform to policies and comply with cGMPs, Health Agency regulations, and all other applicable governing regulations. If you are passionate about quality assurance and continuous improvement, we invite you to apply for this exciting opportunity.
Your Key Responsibilities
- You'll develop and implement the Site Internal Audit Program in alignment with startup activities and schedule.
- Launch and manage the Permanent Inspection Readiness Program to ensure we're always prepared.
- Lead and perform internal audits, including facility, system, and walkthrough audits, while managing the audit schedule.
- Advocate for continuous improvement in our Quality Management Systems, making a substantial impact.
- Maintain and communicate Quality-related metrics for the Site Internal Audit & Inspection Readiness programs.
- Represent the site's Quality Management System during Health Authority Inspections and Global Audits, showcasing our adherence to standards.
- Stay updated on technical, compliance, regulatory, and audit skills to ensure the effectiveness of the audit program.
- You'll communicate audit/inspection results to stakeholders and site leaders, and manage CAPA processes for audits and inspections.
What You Bring to the Team
Required
- You hold a Bachelor’s degree in Biotechnology, Science, or a relevant discipline.
- With 10+ years of experience in the Biopharma/Pharma Industry, including internal audit/Health Authority Inspection experience, you bring a wealth of knowledge.
- Strong knowledge of relevant cGMPs, US and European cGMP guidelines, ICH, and other international regulatory requirements.
- Excellent communication, decision-making, people influencing, and project management skills.
- Strong problem-solving and critical thinking skills with the ability to identify potential compliance issues.
- You are a self-starter with a focus on results and have a desire for continuous learning and improvement.
Preferred
- You have a proven track record in delivering excellence.
- Nice-to-have skills or qualifications include first-hand experience with multiple Health Authority Inspections and a strong motivation to be an inspiring member of a high-performing team
Required Skills:
Audit Management, Biopharmaceuticals, cGMP Training, Critical Thinking, Detail-Oriented, Driving Continuous Improvement, Internal Auditing, International Regulatory Compliance, Leadership, Quality Management System Auditing, Technical Writing
