MSD Senior Specialist QA Vaccines Biological Critical Reagents 

Ireland 

861072581

Job Description

Purpose of the role

Reporting to the Associate Director of Quality Assurance BCR in the US, you will play a crucial role in establishing standardized quality oversight for Biological Critical Reagents (BCR) that support vaccine development. In this newly created global position, you will collaborate with other Senior QA Specialists based in Dunboyne but also across other global GQ-LMAS sites across the world, to lead quality initiatives and enhance the QA strategy for BCRs, ensuring they effectively underpin the advancement of vaccine modalities.

Main tasks

• Performing documentation reviews for the disposition of BCRs, that includes but is not limited to: BCR transfer, qualification, re-evaluation, inventory, and shipping.
• Managing the review and/or approval of analytical GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer.
• Participating in multi-disciplinary meetings to discuss content, progress, and quality of activities within the BCR Hubs.
• Quality representative for BCR hub in Supplier and customer interactions, Training/on-boarding QA of personnel, deviation management, change management, equipment control and disposition of BCRs.
• Remaining informed of current GMP requirements and industry trends in the large molecule, analytical, areas to applicable worldwide regulations and industry standards.
• Providing comments on proposed regulations and communicate impacts to client areas using a risk-based, phase-appropriate approach for decision making.
• Maintaining an expert level of knowledge related to specialized area of technical expertise, specifically for analytical areas.
• Ensuring departmental SOPs reflect departmental procedures and the current regulations.
• Responsibility for oversight of SOPs in supported areas and ensure periodic updates, as appropriate.
• Representing the department or area on project teams or committees establishing GMP, or quality standards, policies, or expectations within the Company.
• Applying technical / quality expertise to help teams remove obstacles, overcoming technical challenges, and making impactful clinical disposition decisions.
• Collaborating with peer leaders in LMAS Quality Assurance to drive strategic initiatives and continuous improvement opportunities.
• Contributing to establishment and sustainability of a safety first, compliance always culture.

Your profile

• Bachelor’s degree in biology, chemistry, engineering or related field.
• A broad and relevant quality assurance background, having gained experience in overseeing analytical sciences in a pharmaceutical company.
• Strong compliance knowledge and understanding of Quality Management Systems, health authority regulations, and interpretation and application of GMPs within a commercial environment.
• Effective communication and collaboration abilities with an entrepreneurial spirit.
• Living within reasonable distance from Dunboyne.
  

Current Contingent Workers apply

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