MSD External Site Quality Leader - AD global role 

Ireland 

567049277

Your Core Responsibilities

• Provide Quality Oversight for External Entities manufacturing or testing cell banks, biologic drug intermediates, substances, or products.

• Ensure productscomply withour company's policies, procedures, and regulations before further processing.

• Oversee Quality Control functions, including product testing, batch documentation review, and deviation investigations.

• Manage the complete processes of transfers, including Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness, and Quality System Oversight Implementation.

• Ensure audit readiness, support regulatory inspections, and manage complaints effectively.

• Oversee change control, conduct metric reviews, and perform annual product reviews.

• Build effective quality systems at External Entities and drive continuous improvement initiatives.

• Exhibit our company's Leadership Behaviors and set a leadership example for the team.

• Maintain compliance with established policies/procedures and all applicable governmental regulations, both domestic and foreign.

Who You Are

• Bachelor's ormaster’s degree in Science, Engineering, or a related field.

• Eight years of relevant experience in the pharmaceutical/biotechnology industry with knowledge of Quality Systems, Quality Assurance, and Quality Control, including global GMP and regulatory requirements.

• Experience with manufacturing operations and/or analyticalexpertisein biologics and/or vaccines, including aseptic manufacturing.

• Competent in analyzing complexproduct, production, and testing issues withdemonstratedscientific problem-solving capabilities.

• Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills.

• Ability to work independently with minimal guidance and proficient in verbal and written communication in English.

• Direct experience managing external partners (CMOs, Labs, etc.).

• Experience in batch disposition, deviation management, change control, andparticipatingin regulatory inspections.

• Knowledge of compliance regulations and standards in regions outside of Europe, such as North America, Asia-Pacific, Latin America, or other relevant markets.

As this role is a remote role in Ireland, Switzerland or Spain travel is