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The role requires cGMP experience, an inspection-ready quality management system, leadership of a Quality team, and cross-functional alignment with customers, collaborators, and vendors. Responsibilities include managing QA systems, lot release, contract manufacturing oversight, regulatory compliance (FDA/EMA), quality risk assessment, audits, investigations, supplier qualification, change control review, and contribution to CMC regulatory content for master files.",{"@graph":63,"@context":118},[64,80,101],{"@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/roosterbio-job-description-directorassociate-director-quality-assurance-qa-cmc-regulatory-24/263427/",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/roosterbio-job-description-directorassociate-director-quality-assurance-qa-cmc-regulatory-24/263427.png","ImageObject",442,249,{"name":88,"@type":89},"Patrick","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-06","2026-09-14",true,{"@type":98,"interactionType":99,"userInteractionCount":79},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the main responsibility of the Director/Associate Director, QA & CMC Regulatory role?","Question",{"text":108,"@type":109},"Assure the quality, safety, and compliance of RoosterBio’s ancillary and cellular starting materials, directing QA strategy and execution across the organization.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which regulatory requirements must the candidate ensure compliance with?",{"text":113,"@type":109},"The document specifies compliance with relevant regulations and guidelines including FDA, EMA, and other international regulatory authorities and requirements.",{"name":115,"@type":106,"acceptedAnswer":116},"What quality systems and activities are part of the hands-on duties?",{"text":117,"@type":109},"The role includes monitoring quality system effectiveness, hosting customer audits, managing supplier/vendor qualification and audits, reviewing change controls/deviations/corrective actions/OOSs/customer complaints, running internal audits, and participating in supplier change and risk evaluations.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},263427,1790284877,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":15,"category_name":16,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":73,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":9},549758146520,"https://ap-avatar.wpscdn.com/avatar/80002397d8c0411e94?_k=1775819394049821470","Director/Associate Director, Quality Assurance (QA) & CMC Regulatory The Company  \nRoosterBio accelerates human mesenchymal stem/stromal cell (hMSC) and exosome/extracellular vesicle (EV) product and process development to fuel the rapid implementation of scalable advanced therapies. Our high-quality hMSCs, bioprocess media, genetic engineering tools, and exosome production solutions are paired with expert bioprocessing knowledge to progress therapeutic developers from concept to firstin-human testing and commercial manufacturing.  \nOur employees are driven by high impact work and are passionate about ensuring our client's success and creating a world where safe and effective advanced therapies are rapidly developed and widely available on a global scale.  \nWe do not compromise on quality, innovation, or product performance. We believe in hiring and developing the best talent available within the industry. The pace is fast, the work is stimulating, and the best is expected out of each team member. It is our belief that an appreciation for a small company environment where a collaborative, solution-focused and high performing culture is of utmost importance is essential to attain personal fulfillment and success at the “Roost”.  \nThe Role  \nWe are seeking a highly motivated, dedicated, and results driven Quality professional to join the team to fill a new role focused on assuring the quality, safety, and compliance of RoosterBio’s ancillary and cellular starting materials for the development and further manufacture of regenerative medicine products in domestic and international markets. This hands-on Director/Associate Director, reporting to the Vice President of Quality and Regulatory, will direct an amazing Quality team to continued success in meeting strategic objectives. The ideal candidate will be highly experienced in cGMP compliance, maintaining an inspection ready quality management system and laboratory, and interfacing across the company as well as with external customers, collaborators, and vendors. Most importantly, the quality minded incumbent should be ambitious, willing to assume increasing responsibilities, and adapt to RoosterBio’s evolving structure and growth.  \nEssential Job Duties  \n• Provide strategic direction and leadership to a top-performing Quality Assurance team to foster a culture of continuous learning and development.  \n• Responsible for the Quality Management System, lot release functions, and operational management of all QA activities to assure the overall quality of RoosterBio products.  \n• Build external relationships with and oversee management of contract manufacturing organizations.  \n• Ensure compliance with relevant regulations and guidelines, including FDA, EMA, and other international regulatory authorities and requirements.  \n• Identify and assess quality risks associated with the business and develop risk mitigation strategies and ensure their effective implementation.  \n• Contribute to department goals by driving implementation of Quality objectives and delivering key results.  \n• Support/lead initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures.  \n• Hands on execution of Quality tasks to support Quality Operations to include  \no Monitoring the effectiveness of quality systems and processes.  \no Preparing for and hosting customer audits including providing any responses.  \no Providing exceptional customer service to internal and external clients, responding to customer inquiries and requests.  \no Oversee supplier/vendor qualification program including leading critical contract vendor auditsas necessary.  \no Review and approve change controls, deviations, corrective actions, OOSs, customer complaints, and other quality system documentation.  \no Oversee internal audits to assess compliance with quality standards. Lead the internal audit program to monitor RoosterBio’s state of compliance.  \no Cond","cbCaisDkPgKyqiWu","https://ap.wps.com/l/cbCaisDkPgKyqiWu","pdf",144472,"English","# Essential Job Duties\n## Quality Management System and Compliance\n## Audits, Investigations, and Supplier Oversight\n## CMC Regulatory Support\n# Skills/Qualifications\n# Application Instructions","[{\"question\":\"What is the main responsibility of the Director/Associate Director, QA \\u0026 CMC Regulatory role?\",\"answer\":\"Assure the quality, safety, and compliance of RoosterBio’s ancillary and cellular starting materials, directing QA strategy and execution across the organization.\"},{\"question\":\"Which regulatory requirements must the candidate ensure compliance with?\",\"answer\":\"The document specifies compliance with relevant regulations and guidelines including FDA, EMA, and other international regulatory authorities and requirements.\"},{\"question\":\"What quality systems and activities are part of the hands-on duties?\",\"answer\":\"The role includes monitoring quality system effectiveness, hosting customer audits, managing supplier/vendor qualification and audits, reviewing change controls/deviations/corrective actions/OOSs/customer complaints, running internal audits, and participating in supplier change and risk evaluations.\"}]","RoosterBio - Job Description - Director/Associate Director, Quality Assurance (QA) & CMC Regulatory - 24 | PDF",1789370902]