[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-259018-105":53,"doc-detail-259018-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","cs-cr-quality-compliance-manager-job-description","CS CR Quality Compliance Manager - Job Description","","CS CR Quality Compliance Manager role within Almac Clinical Services supports Qualified Persons (UK and IE) to ensure Clinical Supplies release meets regulatory and customer requirements within agreed timelines. Responsibilities include acting as the primary QP Services contact, coordinating customer kick-offs, overseeing study delivery against KPIs, and developing customer relationships while tracking and escalating performance or quality concerns. The role also ensures GMP compliance, accurate documentation readiness for audits, review of regulatory history and audit reports, management of expiry updates, and continuous process improvement. Customer service duties cover queries, complaints, meetings, and representation during audits and sales visits.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":16,"@type":70,"position":76},"https://docshare.wps.com/template/resumes/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/cs-cr-quality-compliance-manager-job-description/259018/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/cs-cr-quality-compliance-manager-job-description/259018.png","ImageObject",442,249,{"name":88,"@type":89},"Riley West","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-21","2026-09-13",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",8,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the overall objective of the CS CR Quality Compliance Manager role?","Question",{"text":109,"@type":110},"Support Qualified Persons (UK and IE) to ensure release of Clinical Supplies aligns with regulatory and customer expectations within agreed timelines.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"Which responsibilities focus on managing studies and service performance?",{"text":114,"@type":110},"Oversee assigned studies, manage delivery of associated activities, track and report performance against timelines and KPIs, and take action when performance falls short.",{"name":116,"@type":107,"acceptedAnswer":117},"How does the role ensure regulatory and audit readiness?",{"text":118,"@type":110},"Maintain information and documentation to a high standard in accordance with SOPs, keep an audit/inspection-ready state, and review site regulatory history, QP declarations, and audit reports with corrective actions.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},259018,1790350495,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":15,"category_name":16,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":47,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":73},1099523885074,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","JOB DESCRIPTION  \n\n| JOB DESCRIPTION CREATION DATE: | June 2021 |\n| --- | --- |\n| POSITION: |  CS CR Quality Compliance Manager  |\n| BUSINESS UNIT: | Clinical Services |\n| LOCATION: | Craigavon |\n| REPORTING TO: | CS CR Quality Compliance Team Leader |\n\nRESPONSIBLE FOR (PEOPLE):  N/A  \nOVERALL ROLE OBJECTIVE:  \nThe Quality Compliance Manager will support the Almac Clinical Services Qualified Persons (UK and IE) to ensure that release of Clinical Supplies is in line with regulatory and customer expectations and within agreed timelines.  \nJOB SPECIFIC RESPONSIBILITIES:  \nThe post holder will:  \n1 Act as a principle contact for the customer requiring QP Services, keeping up to date with Clinical Trial legislation and providing expert advice in a consultancy capacity.  \n2 Host a kick-off teleconference with the customer to advise on the QP Services offering and determine the requirements for products involved in their studies.  \n3 Oversee assigned studies and manage the delivery of associated activities ensuring that enhanced focus is given to the quality of the service provided, in accordance with the associated timelines , KPI’s and customer expectations. Track and report on delivery and take action when performance falls short of expectations.  \n4 Develop relationships with assigned customers and maintain a knowledge of their requirements in order to deliver on commitments. Closely monitor any issues and endeavour to resolve these before they escalate. In doing so, attend teleconference and meetings (as required) to ensure a high level of customer service.  \n5 Liaise with Quality Compliance Co-ordinators, Auditors and the Planner to ensure that activities are being performed in accordance with scheduled timelines and that data is accurately recorded to continuously monitor performance and output.  \n6 Advise on QP related activities and responsibilities during the generation/revision of Technical Agreements and compile QP to QP Agreements.  \n7 Perform delegated duties on behalf of the QP ensuring compliance with GMP, the Product Specification File and the Clinical Trial Authorisation , ensuring any safety, compliance or regulatory concerns are escalated to the QP.  \n8 Review site regulatory history, compile or review QP Declarations, and present to the QP for assessment along with any supporting documentation.  \n9 Review audit reports and proposed corrective actions to ensure adherence to the required standards of GMP. Escalate any concerns to the QP in a timely manner.  \n10 Ensure all information and documentation is completed and maintained to a high standard according to the SOP and constantly in an audit / inspectionready state.  \n11 Assess stability data in light of pending expiry updates and approve any Expiry Date memos as applicable.  \n12 Ascertain the status of the Clinical Trial Application in each participating country prior to release, considering the impact of substantial amendments or notifications to the Clinical Trial Application.  \n13 Continuously assess current processes to identify improvements and efficiencies. Advise management and implement any actions following agreement.  \n14 Proactively escalate issues to the Quality Compliance Team Leader and the Quality Compliance Group Manager as appropriate.  \nCustomer Service Duties  \n1 Ensure all customer contact, oral and written, is carried out professionally in order to develop and maintain good working relationships with each customer.  \n2 Manage the implementation of customer specific processes as and when required.  \n3 Participate in Business Review Meetings (BRMs) for key customers as necessary which may involve preparing and delivering presentations.  \n4 Receive and follow through on all customer queries received, ensuring a response is supplied in a timely manner.  \n5 Escalate any customer complaints in accordance with the relevant procedure.  \n6 Co-ordinate/attend internal/external teleconferences/meetings, initiating Qualified Person related discussions ","cbCaifId4DqyCU2X","https://ap.wps.com/l/cbCaifId4DqyCU2X","pdf",132513,"English","# Job Role Objective\n# Job Specific Responsibilities\n## Customer Service Duties\n# General Role Responsibilities\n## Quality\n## Health & Safety\n## Training and Development\n## Human Resource Management\n## Communication\n## Equal Opportunities\n## Core Competency Framework\n# Acceptance and Signature","[{\"question\":\"What is the overall objective of the CS CR Quality Compliance Manager role?\",\"answer\":\"Support Qualified Persons (UK and IE) to ensure release of Clinical Supplies aligns with regulatory and customer expectations within agreed timelines.\"},{\"question\":\"Which responsibilities focus on managing studies and service performance?\",\"answer\":\"Oversee assigned studies, manage delivery of associated activities, track and report performance against timelines and KPIs, and take action when performance falls short.\"},{\"question\":\"How does the role ensure regulatory and audit readiness?\",\"answer\":\"Maintain information and documentation to a high standard in accordance with SOPs, keep an audit/inspection-ready state, and review site regulatory history, QP declarations, and audit reports with corrective actions.\"}]","CS CR Quality Compliance Manager - Job Description | PDF",1789328666]