{"id":7064140,"date":"2025-08-01T12:41:14","date_gmt":"2025-08-01T12:41:14","guid":{"rendered":"https:\/\/jeffersonwells.be\/vacancies\/26442-external-operations-quality-partner\/"},"modified":"2025-08-01T12:41:14","modified_gmt":"2025-08-01T12:41:14","slug":"26442-external-operations-quality-partner","status":"publish","type":"matador-job-listings","link":"https:\/\/jeffersonwells.be\/nl\/vacancies\/26442-external-operations-quality-partner\/","title":{"rendered":"External Operations Quality Partner"},"content":{"rendered":" <ul class=\"matador-job-meta matador-job-meta-job-7064140 matador-job-meta-default\"> <li class=\"matador-job-meta-field matador-job-field-job_general_location matador-job-field-value-braine-lalleud\"> <span class=\"matador-job-meta-label\">Locatie:<\/span> <span class=\"matador-job-meta-value\">Braine-l&#039;Alleud<\/span> <\/li> <li class=\"matador-job-meta-field matador-job-field-bullhorn_job_id matador-job-field-value-26442\"> <span class=\"matador-job-meta-label\">Vacature<\/span> <span class=\"matador-job-meta-value\">#26442<\/span> <\/li> <\/ul> <h1><span><span><strong>External Operations Quality Partner&nbsp;<\/strong><\/span><\/span><br \/> <span><span>Brabant Wallon \u2013 Contracting&nbsp;<\/span><\/span><br \/> <span><span><strong>What are your responsibilities?<\/strong><\/span><\/span><\/h1> <ul> <li> <h1><span><span>Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).<\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Provide timely and efficient GMP\/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP\/GDP, health and safety, etc..<\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements. <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors \/ Suppliers \/ in house). <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out \/ Change management \/ complaints \/ quality improvement). <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions. <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Provide support in the evaluation of Temperature excursions for IMP. <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Management of Quality Complaints of IMP. <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits. <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc\u2026) <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Contribute the preparation of audits (internal\/external, regulatory inspections) <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Lead internal audits \/ Self-Inspections<\/span><\/span><\/h1> <\/li> <\/ul> <h1><span><span><strong>Who are you?<\/strong><\/span><\/span><\/h1> <ul> <li> <h1><span><span>5 years\u2019 experience in QA\/compliance experience in pharmaceutical regulated environment <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese) <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Strong experience in batch review.<\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Quality mindset with a pragmatic and proactive approach.<\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Fluent in English is a must and French is a nice to have.<\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Experience working with CMOs and vendors.<\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Familiarity with GMP and GDP standards.<\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Experience with quality systems (deviation management, complaints, change control)<\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Familiarity with clinical packaging environments (vs. commercial) is a plus <\/span><\/span><\/h1> <\/li> <li> <h1><span><span>Certified auditor status is a plus.<\/span><\/span><\/h1> <\/li> <\/ul> <h1><span><span><strong>Our offer?<\/strong><\/span><\/span><br \/> <span><span><strong>Jefferson Wells<\/strong> offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You\u2019re interested in this job? We invite you to apply!&nbsp;<\/span><\/span><\/h1> <nav class=\"matador-job-navigation\"> <ul> <li> <a href=\"https:\/\/jeffersonwells.be\/nl\/vacancies\/26442-external-operations-quality-partner\/\" rel=\"button\" class=\"matador-button\" title=\"Solliciteren Direct\">Solliciteren Direct<\/a> <\/li> <\/ul> <\/nav> ","protected":false},"excerpt":{"rendered":"<p>Locatie: Braine-l&#039;Alleud Vacature #26442 External Operations Quality Partner&nbsp; Brabant Wallon \u2013 Contracting&nbsp; What are your responsibilities? Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions). Provide timely and efficient GMP\/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects Support compliance with &hellip; <a href=\"https:\/\/jeffersonwells.be\/nl\/vacancies\/26442-external-operations-quality-partner\/\" class=\"more-link\">Lees verder <span class=\"screen-reader-text\">&#8220;External Operations Quality Partner&#8221;<\/span><\/a><\/p>\n","protected":false},"template":"","meta":{"_matador_source_id":"26442"},"matador-categories":[1420592],"matador-locations":[1420020],"matador-types":[1419976],"matador-provinces":[1420489],"class_list":["post-7064140","matador-job-listings","type-matador-job-listings","status-publish","hentry","matador-categories-life-sciences","matador-locations-braine-lalleud","matador-types-contracting","matador-provinces-walloon-brabant"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>External Operations Quality Partner - Jefferson Wells<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jeffersonwells.be\/vacancies\/26442-external-operations-quality-partner\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"External Operations Quality Partner - Jefferson Wells\" \/>\n<meta property=\"og:description\" content=\"Locatie: Braine-l&#039;Alleud Vacature #26442 External Operations Quality Partner&nbsp; Brabant Wallon \u2013 Contracting&nbsp; What are your responsibilities? 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