External Site Quality Leader - AD, global role

<p><b>Job Description</b></p><p></p><p><span><span>Join our company, a premier research-intensive biopharmaceutical organization, where we are at the forefront of delivering innovative health solutions. As an External Site Quality Leader (ESQL), you will play a critical role in ensuring the highest standards of quality and compliance in our manufacturing and testing operations. This is an exciting opportunity to be part of a global network dedicated to delivering reliable and compliant products to our customers and patients.</span></span><span> </span></p><p></p><p><b><span>Your Core Responsibilities</span></b><span> </span></p><ul><li><p><span><span>Provide Quality Oversight for External Entities manufacturing or testing cell banks, biologic drug intermediates, substances, or products.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ensure products </span><span>comply with</span><span> our company's policies, procedures, and regulations before further processing.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Oversee Quality Control functions, including product testing, batch documentation review, and deviation investigations.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Manage the complete processes of transfers, including Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness, and Quality System Oversight Implementation.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ensure audit readiness, support regulatory inspections, and manage complaints effectively.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Oversee change control, conduct metric reviews, and perform annual product reviews.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Build effective quality systems at External Entities and drive continuous improvement initiatives.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Exhibit our company's Leadership Behaviors and set a leadership example for the team.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Maintain compliance with established policies/procedures and all applicable governmental regulations, both domestic and foreign.</span></span><span> </span></p></li></ul><p><b><span>Who You Are</span></b><span> </span></p><p><span>You are ready if you have:</span><span> </span></p><ul><li><p><span><span>Bachelor's or </span><span>master’s degree in Science</span><span>, Engineering, or a related field.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Eight years of relevant experience in the <span>pharmaceutical/biotechnology</span> industry with knowledge of Quality Systems, Quality Assurance, and Quality Control, including global GMP and regulatory requirements.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Experience with manufacturing operations and/or analytical </span><span>expertise</span><span> in biologics and/or vaccines, including aseptic manufacturing.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Competent in analyzing complex </span><span>product</span><span>, production, and testing issues with </span><span>demonstrated</span><span> scientific problem-solving capabilities.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ability to work independently with minimal guidance and proficient in verbal and written communication in English.</span></span><span> </span></p></li></ul><p><span>Nice to have, but not essential:</span><span> </span></p><ul><li><p><span><span>Direct experience managing external partners (CMOs, Labs, etc.).</span></span><span> </span></p></li></ul><ul><li><p><span><span>Experience in batch disposition, deviation management, change control, and </span><span>participating</span><span> in regulatory inspections.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Knowledge of compliance regulations and standards in regions outside of Europe, such as North America, Asia-Pacific, Latin America, or other relevant markets.</span></span><span> </span></p></li></ul><p><span> </span></p><p><b><span>As this role is a remote role in Ireland, Switzerland or Spain travel is </span><span>required</span><span> (outside of the EU) - 20%, occasionally on short notice.</span></b><span><span> You must be based in one of these countries for your application to be considered.</span></span><span> </span></p><p></p><p>Current Employees apply <a href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p>Current Contingent Workers apply <a href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p><b>Secondary</b><b> Language(s) Job Description:</b></p><p></p><p></p><p><span>As a comp