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Position Summary
The Quality System Manager, under the supervision of Quality Leadership, is responsible for executing and supporting day-to-day activities of GxP quality systems, with particular emphasis on document control, change control, and deviation management. This role ensures that quality processes are implemented in compliance with applicable regulatory requirements (FDA, EMA, ICH, ISO) and internal quality standards to maintain inspection readiness and support product development through commercialization. Key Responsibilities
Document Control Administer the electronic Document Management System (eDMS) ensuring documents are created, reviewed, approved, distributed, and archived in compliance with regulatory and company standards. Coordinate controlled document lifecycle: drafting, formatting, issuance, revision, retirement, and archival. Maintain document templates, numbering systems, and access permissions. Ensure training assignments are linked to new/revised documents. Change Control Facilitate change control process by logging, tracking, and monitoring changes to GxP systems, procedures, and controlled documents. Assist in risk assessment and impact analysis of proposed changes. Coordinate cross-functional review and approval of change requests, ensuring timely closure. Generate periodic reports on open and completed change controls for management review. Deviation / Nonconformance Management Log and track deviations, errors, or nonconformances in the Quality Management System (QMS). Coordinate investigation activities, ensuring root cause analysis and appropriate corrective and preventive actions (CAPAs) are documented. Monitor deviation and CAPA timelines to ensure compliance with internal metrics and regulatory expectations. Support trending and data analysis to identify recurring issues and opportunities for process improvement. Training Support Administer the required training related to SOPs, policies, and GxP compliance. Ensure training completion records are accurate and audit ready. Audit and Inspection Readiness Maintain accurate and complete quality records to ensure inspection readiness at all times. Support preparation for internal audits, external audits, and regulatory inspections. Provide documentation and records retrieval during audits and inspections. Metrics and Reporting Generate routine metrics on document control, change control, deviations, and CAPA performance. Support preparation of data for Quality Management Reviews (QMR). Continuous Improvement Proactively identify areas for process improvement within quality systems. Support initiatives to streamline workflows, enhance compliance, and increase efficiency. Qualifications
Education Bachelors degree in Life Sciences, Quality Assurance, Regulatory Affairs, or a related discipline (or equivalent work experience). Experience 4-8 years of experience in a GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry). Experience with electronic Quality Management Systems (eQMS), Document Management Systems, or Learning Management Systems. Knowledge and Skill Understanding of FDA, EMA, and ICH GxP regulations and guidelines. Strong organizational and time-management skills with ability to manage multiple priorities. Excellent written and verbal communication skills. Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook). Attention to detail and commitment to data integrity. Attributes
Prior experience working in a company advancing a product from late-stage development to commercial launch. Hands-on experience implementing or scaling electronic QMS tools and inspection readiness platforms. Why Join Arthrosi?
Opportunity to make a significant contribution to addressing a disease with significant unmet medical need. Opportunity to make a significant impact in a small, agile organization advancing a promising late-stage oral therapeutic. Dynamic and collaborative environment where science, innovation, and execution come together. Competitive compensation and equity participation with high-growth potential. Flexible work model and a mission-driven culture anchored in scientific excellence and patient impact.
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The Quality System Manager, under the supervision of Quality Leadership, is responsible for executing and supporting day-to-day activities of GxP quality systems, with particular emphasis on document control, change control, and deviation management. This role ensures that quality processes are implemented in compliance with applicable regulatory requirements (FDA, EMA, ICH, ISO) and internal quality standards to maintain inspection readiness and support product development through commercialization. Key Responsibilities
Document Control Administer the electronic Document Management System (eDMS) ensuring documents are created, reviewed, approved, distributed, and archived in compliance with regulatory and company standards. Coordinate controlled document lifecycle: drafting, formatting, issuance, revision, retirement, and archival. Maintain document templates, numbering systems, and access permissions. Ensure training assignments are linked to new/revised documents. Change Control Facilitate change control process by logging, tracking, and monitoring changes to GxP systems, procedures, and controlled documents. Assist in risk assessment and impact analysis of proposed changes. Coordinate cross-functional review and approval of change requests, ensuring timely closure. Generate periodic reports on open and completed change controls for management review. Deviation / Nonconformance Management Log and track deviations, errors, or nonconformances in the Quality Management System (QMS). Coordinate investigation activities, ensuring root cause analysis and appropriate corrective and preventive actions (CAPAs) are documented. Monitor deviation and CAPA timelines to ensure compliance with internal metrics and regulatory expectations. Support trending and data analysis to identify recurring issues and opportunities for process improvement. Training Support Administer the required training related to SOPs, policies, and GxP compliance. Ensure training completion records are accurate and audit ready. Audit and Inspection Readiness Maintain accurate and complete quality records to ensure inspection readiness at all times. Support preparation for internal audits, external audits, and regulatory inspections. Provide documentation and records retrieval during audits and inspections. Metrics and Reporting Generate routine metrics on document control, change control, deviations, and CAPA performance. Support preparation of data for Quality Management Reviews (QMR). Continuous Improvement Proactively identify areas for process improvement within quality systems. Support initiatives to streamline workflows, enhance compliance, and increase efficiency. Qualifications
Education Bachelors degree in Life Sciences, Quality Assurance, Regulatory Affairs, or a related discipline (or equivalent work experience). Experience 4-8 years of experience in a GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry). Experience with electronic Quality Management Systems (eQMS), Document Management Systems, or Learning Management Systems. Knowledge and Skill Understanding of FDA, EMA, and ICH GxP regulations and guidelines. Strong organizational and time-management skills with ability to manage multiple priorities. Excellent written and verbal communication skills. Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook). Attention to detail and commitment to data integrity. Attributes
Prior experience working in a company advancing a product from late-stage development to commercial launch. Hands-on experience implementing or scaling electronic QMS tools and inspection readiness platforms. Why Join Arthrosi?
Opportunity to make a significant contribution to addressing a disease with significant unmet medical need. Opportunity to make a significant impact in a small, agile organization advancing a promising late-stage oral therapeutic. Dynamic and collaborative environment where science, innovation, and execution come together. Competitive compensation and equity participation with high-growth potential. Flexible work model and a mission-driven culture anchored in scientific excellence and patient impact.
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