Site Lead Auditor, Associate Director - Dundalk

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
** Stay updated on technical, compliance, regulatory, and audit skills to ensure the effectiveness of the audit program. 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.

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
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Job Description:

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