Job Summary
This role requires expertise and leadership in the quality function to ensure licensed product is certified and released to market in compliance with commercial manufacturing license and clinical products.
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Key Responsibilities
* Ensure batch disposition of quality in the Industrial Operations and Product Supply organization.
* Dispose of medicinal products and interact with biotechnology commercial and clinical API and fill/finish manufacturing operations, facilities, and quality control laboratories to ensure compliance.
* Partner with contract manufacturers to resolve compliance issues and negotiate third-party contractor and supplier quality agreements.
* Coordinate QA resources and prioritize activities with area management.
* Participate in cross-functional teams as Quality/Qualified Person representative.
* Provide advice and direction to other departments on quality and regulatory issues.
* Audit sites on behalf of Regeneron Ireland and prepare for Regulatory Agency interactions.
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Requirements
* 5 years of experience as Qualified Person, named on the Manufacturing and Importation Authorisation (MIA) license.
* Expert knowledge of 2001/83/EC and Annex 16, Eudra Lex, Volume 4, EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use.
* Ability to research, analyze, and extrapolate critical regulatory information.
* Team-oriented and positive relationship builder.
* Ability to collaborate with individuals across the organization at all levels.
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Qualifications
* Third-level qualification (degree in science or related discipline preferred) appropriate for QP eligibility.
* Minimum of 8 years of related experience in the pharmaceutical and/or biotechnology industry.