{"id":625,"date":"2025-11-17T16:03:06","date_gmt":"2025-11-17T16:03:06","guid":{"rendered":"https:\/\/skillbasedmatching.com\/jobs\/?post_type=jobpost&#038;p=625"},"modified":"2025-11-17T16:03:09","modified_gmt":"2025-11-17T16:03:09","slug":"gxp-systems-administrator-research-development-rd","status":"publish","type":"jobpost","link":"https:\/\/skillbasedmatching.com\/jobs\/current-jobs\/gxp-systems-administrator-research-development-rd\/","title":{"rendered":"GxP Systems Administrator \u2013 Research &#038; Development (R&#038;D)"},"content":{"rendered":"\n<p>\u200bPlanet Pharma is seeking a <strong>GxP Systems Administrator<\/strong> to join the Information Sciences team supporting a client&#8217;s Research &amp; Development functions. This individual will provide day-to-day administration, user management, and operational support for GxP-compliant SaaS platforms, working remotely on a contract basis. The administrator reports to the Senior Manager, GxP Business Systems, and collaborates closely with CSV and Quality teams.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u200b<strong>Location:<\/strong> Remote (Listed base location: Redwood City, CA)<\/li>\n\n\n\n<li>\u200b<strong>Employment Type:<\/strong> Contract<\/li>\n\n\n\n<li>\u200b<strong>Experience:<\/strong> Required experience supporting GxP-regulated environments in pharma, life sciences, or related industries.<\/li>\n\n\n\n<li>\u200b<strong>Focus:<\/strong> User access management, troubleshooting, implementation support, and ensuring regulatory compliance (21 CFR Part 11, Annex 11, GAMP 5) and the validated state of R&amp;D systems.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">\u200bKey Responsibilities: Compliance and System Integrity<\/h3>\n\n\n\n<p>\u200bThe administrator is key to maintaining system integrity, regulatory adherence, and operational efficiency for R&amp;D.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u200b<strong>System Compliance &amp; Administration:<\/strong> Administer and support GxP systems in compliance with regulations like <strong>21 CFR Part 11, Annex 11, and GAMP 5<\/strong>.<\/li>\n\n\n\n<li>\u200b<strong>User &amp; Access Management:<\/strong> Manage user access for GxP (and occasionally non-GxP) R&amp;D platforms, including <strong>provisioning, modifying, and deactivating user accounts<\/strong>.<\/li>\n\n\n\n<li>\u200b<strong>Support &amp; Troubleshooting:<\/strong> Troubleshoot and resolve support requests and incidents related to GxP systems in a timely and precise manner.<\/li>\n\n\n\n<li>\u200b<strong>Routine Activities:<\/strong> Perform steady-state tasks such as <strong>periodic user access reviews<\/strong> and <strong>audit trail reviews<\/strong> per company procedures.<\/li>\n\n\n\n<li>\u200b<strong>Validation Support:<\/strong> Support the implementation and maintenance of new GxP systems, including <strong>validation activities<\/strong> and system documentation (e.g., specifications, user guides).<\/li>\n\n\n\n<li>\u200b<strong>Collaboration:<\/strong> Collaborate with Quality, Regulatory, Clinical, and IT teams to ensure systems are effectively managed and remain in a validated state.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">\u200bRequired and Preferred Qualifications: GxP and Veeva<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u200b<strong>Required:<\/strong> Direct experience administering <strong>GxP quality and regulatory platforms<\/strong>. Strong technical skills, attention to detail, and efficient time management. Basic understanding of <strong>GAMP 5<\/strong> and US\/international GxP regulations.<\/li>\n\n\n\n<li>\u200b<strong>Preferred Experience:<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u200b<strong>Veeva Vault White Belt certification<\/strong> or 2+ years&#8217; experience configuring Veeva Vault (Quality, RIMS).<\/li>\n\n\n\n<li>\u200bDirect experience administering eTMF (Trial Interactive), <strong>DocuSign Part 11<\/strong>, and Lorenz Docubridge.<\/li>\n\n\n\n<li>\u200b<strong>In depth understanding of Computer System Validation (CSV)<\/strong> principles, SDLC, and 21 CFR Part 11 compliance.<\/li>\n\n\n\n<li>\u200bBasic scripting or automation skills (<strong>Python, PowerShell<\/strong>).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\u200bPlanet Pharma is seeking a GxP Systems Administrator to join the Information Sciences team supporting a client&#8217;s Research &amp; Development functions. This individual will provide day-to-day administration, user management, and operational support for GxP-compliant SaaS platforms, working remotely on a contract basis. The administrator reports to the Senior Manager, GxP Business Systems, and collaborates closely [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"menu_order":0,"template":"","jobpost_category":[46,648],"jobpost_job_type":[39],"jobpost_location":[],"jobpost_tag":[2944,2945,2947,2941,2638,2942,2914,2946,2948,2943],"class_list":["post-625","jobpost","type-jobpost","status-publish","hentry","jobpost_category-data","jobpost_category-information-technology","jobpost_job_type-remote","jobpost_tag-21-cfr-part-11","jobpost_tag-csv","jobpost_tag-gamp-5","jobpost_tag-gxp-systems-administrator","jobpost_tag-life-sciences","jobpost_tag-rd-systems","jobpost_tag-remote-contract","jobpost_tag-system-validation","jobpost_tag-user-access-management","jobpost_tag-veeva-vault"],"_links":{"self":[{"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/jobpost\/625","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/jobpost"}],"about":[{"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/types\/jobpost"}],"author":[{"embeddable":true,"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/users\/1"}],"wp:attachment":[{"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/media?parent=625"}],"wp:term":[{"taxonomy":"jobpost_category","embeddable":true,"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/jobpost_category?post=625"},{"taxonomy":"jobpost_job_type","embeddable":true,"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/jobpost_job_type?post=625"},{"taxonomy":"jobpost_location","embeddable":true,"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/jobpost_location?post=625"},{"taxonomy":"jobpost_tag","embeddable":true,"href":"https:\/\/skillbasedmatching.com\/jobs\/wp-json\/wp\/v2\/jobpost_tag?post=625"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}