... based audit planning, remote and on-site audit strategies, audit execution standards, and ... Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech ...
... based audit planning, remote and on-site audit strategies, audit execution standards, and ... Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech ...
Director, Vendor Quality Management
Cambridge, MA · On-site +1
... based audit planning, remote and on-site audit strategies, audit execution standards, and ... Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech ...
Quick apply
Director, Vendor Quality Management
Cambridge, MA · On-site +1
... based audit planning, remote and on-site audit strategies, audit execution standards, and ... Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech ...
Senior QA Enginerer
Waltham, MA · Remote
You will also work with cross-functional teams work with developers, Product Managers and Remote QA ... Hands-on experience with Linux/Unix operating systems * Solid understanding of backup and ...
Senior QA Enginerer
Waltham, MA · Remote
You will also work with cross-functional teams work with developers, Product Managers and Remote QA ... Hands-on experience with Linux/Unix operating systems * Solid understanding of backup and ...
QA/RA Consultant
Boston, MA · On-site +1
$130K - $150K/yr
Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about ...
QA/RA Consultant
Boston, MA · On-site +1
$130K - $150K/yr
Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about ...
Oversee system lifecycle activities including impact assessments, change management, periodic ... At Amylyx, we proudly support remote work opportunities within the United States. However, due to ...
Oversee system lifecycle activities including impact assessments, change management, periodic ... At Amylyx, we proudly support remote work opportunities within the United States. However, due to ...
QA/RA Consultant
Boston, MA · On-site +1
$130K - $150K/yr
Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about ...
QA/RA Consultant
Boston, MA · On-site +1
$130K - $150K/yr
Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about ...
QA/RA Consultant
Boston, MA · On-site +1
$130K - $150K/yr
Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about ...
QA/RA Consultant
Boston, MA · On-site +1
$130K - $150K/yr
Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about ...
What You'll Do As a QA Engineer focused on ML/AI systems , your mission is to ensure the ... Remote first company * Competitive salary and equity * Flexible hours and remote-friendly culture
Quick apply
What You'll Do As a QA Engineer focused on ML/AI systems , your mission is to ensure the ... Remote first company * Competitive salary and equity * Flexible hours and remote-friendly culture
Conduct on-site, hybrid, and/or remote vendor or clinical site audits and or inspection readiness ... Support activities related to key Quality Management System (QMS) programs, including Supplier ...
Conduct on-site, hybrid, and/or remote vendor or clinical site audits and or inspection readiness ... Support activities related to key Quality Management System (QMS) programs, including Supplier ...
Head of Quality Assurance
Cambridge, MA · On-site +1
Oversee, maintain, and continuously enhance the Quality Management System (QMS) * Serve as a senior leader during sponsor audits and regulatory inspections * Drive modernization of QA through ...
Head of Quality Assurance
Cambridge, MA · On-site +1
Oversee, maintain, and continuously enhance the Quality Management System (QMS) * Serve as a senior leader during sponsor audits and regulatory inspections * Drive modernization of QA through ...
Lead Quality Systems Auditor
Waltham, MA · On-site +1
... System (QM) audits required by the corporate quality systems audit program, including planning ... Support external quality management inspections at Fresenius Medical Care sites and distribution ...
Lead Quality Systems Auditor
Waltham, MA · On-site +1
... System (QM) audits required by the corporate quality systems audit program, including planning ... Support external quality management inspections at Fresenius Medical Care sites and distribution ...
Lead Quality Systems Auditor
Waltham, MA · On-site +1
... System (QM) audits required by the corporate quality systems audit program, including planning ... Support external quality management inspections at Fresenius Medical Care sites and distribution ...
Lead Quality Systems Auditor
Waltham, MA · On-site +1
... System (QM) audits required by the corporate quality systems audit program, including planning ... Support external quality management inspections at Fresenius Medical Care sites and distribution ...
Associate Director, Audit Management
Boston, MA · Remote
$154.60K - $231.80K/yr
GxP quality systems, including GCP/GLP audit processes * Regional/international knowledge of GCP ... Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be ...
Associate Director, Audit Management
Boston, MA · Remote
$154.60K - $231.80K/yr
GxP quality systems, including GCP/GLP audit processes * Regional/international knowledge of GCP ... Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be ...
Remote; Waltham, MA area candidates preferred. Role Overview: The Director, Clinical Quality ... systems relevant to quality oversight. * Experience with risk-based quality management and quality ...
Remote; Waltham, MA area candidates preferred. Role Overview: The Director, Clinical Quality ... systems relevant to quality oversight. * Experience with risk-based quality management and quality ...
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management ... Remote Monitoring & Diagnostics Basic knowledge of project planning and execution Demonstrated ...
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management ... Remote Monitoring & Diagnostics Basic knowledge of project planning and execution Demonstrated ...
Review client's quality management system documentation * Verify and document evidence of ... Remote #LI-JC1 * Intertek does not accept unsolicited approaches from agencies and will not pay a ...
Review client's quality management system documentation * Verify and document evidence of ... Remote #LI-JC1 * Intertek does not accept unsolicited approaches from agencies and will not pay a ...
Commercial or aerospace / defense Quality Management System regulations and standards- AS9100 ... Remote: This position currently is designated as remote. Employees who are working in remote roles ...
Commercial or aerospace / defense Quality Management System regulations and standards- AS9100 ... Remote: This position currently is designated as remote. Employees who are working in remote roles ...
Remote About BigRio: BigRio is a remote technology consulting firm based in Boston. We offer ... in system integration and automation projects. Our goal is to deliver tailored, high-quality ...
Remote About BigRio: BigRio is a remote technology consulting firm based in Boston. We offer ... in system integration and automation projects. Our goal is to deliver tailored, high-quality ...
Federal Healthcare Risk Management Nurse (DHA CQM Program) Fully Remote-United States Job Type ... Familiar with Centralized Credentials Quality Assurance System (CCQAS) or a similar Credentialing ...
Federal Healthcare Risk Management Nurse (DHA CQM Program) Fully Remote-United States Job Type ... Familiar with Centralized Credentials Quality Assurance System (CCQAS) or a similar Credentialing ...
Quality Management System (QMS) assessment and remediation * Inspection readiness, mock inspections, inspection training * Data integrity, risk management, and compliance transformation * Quality ...
Quality Management System (QMS) assessment and remediation * Inspection readiness, mock inspections, inspection training * Data integrity, risk management, and compliance transformation * Quality ...
Remote Quality Management System information
What are the key skills and qualifications needed to thrive as a Remote Quality Management System (QMS) Specialist, and why are they important?
How does a Remote Quality Management System professional typically collaborate with cross-functional teams to maintain compliance and quality standards?
What is a Remote Quality Management System?
What is the difference between Remote Quality Management System vs Remote Quality Assurance Specialist?
| Aspect | Remote Quality Management System | Remote Quality Assurance Specialist |
|---|---|---|
| Certifications | ISO 9001, CQE, Six Sigma | ISO 9001, CQE, Six Sigma |
| Work Environment | Software-focused, process-oriented | Product-focused, testing and compliance |
| Industry Usage | Manufacturing, healthcare, tech | Manufacturing, software, healthcare |
Both roles often require similar certifications and work in industries emphasizing quality standards. However, Remote Quality Management System professionals focus on implementing and maintaining quality management software and processes, while Remote Quality Assurance Specialists concentrate on testing, inspections, and ensuring product compliance remotely.
- Remote 80 Dollars An Hour
- Utilization Review Specialist Remote
- Remote Medical Monitor
- Clinical Denials Coding Review Specialist
- Remote Independent Medical Examination Transcription
- Remote Data Quality Reviewer
- Remote Organizational Management
- Night Shift Remote Medical Customer Service
- Remote Coding
- Remote Radiology Coding

Job description
- Lead the implementation of a global, risk-based GxP vendor oversight program aligned with industry best practices and global regulatory expectations (e.g., ICH Q9, data integrity principles, and applicable GxP requirements), ensuring scalability to support commercial operations.
- Establish and operationalize an end-to-end vendor lifecycle management framework, including vendor selection, qualification, onboarding, performance monitoring, issue and CAPA management, change management, periodic review, requalification, and vendor termination activities.
- Develop and implement a tiered vendor segmentation and risk methodology, defining vendor criticality classifications, risk scoring criteria, oversight requirements, and triggers for enhanced monitoring and requalification activities.
- Build and mature a right-sized audit and monitoring program proportional to vendor risk and criticality, including risk-based audit planning, remote and on-site audit strategies, audit execution standards, and integration of audit outcomes into CAPA and management review processes.
- Define and implement vendor oversight governance mechanisms, including KPIs, dashboards, management review processes, escalation pathways, and periodic business reviews to enable proactive performance and compliance management.
- Partner cross-functionally with Quality, Supply Chain, Manufacturing, Technical Operations, Regulatory, and IT teams to ensure alignment of vendor oversight activities with business objectives and regulatory expectations.
- Lead technology enablement efforts supporting vendor oversight processes, including assessment and optimization of eQMS and related systems (e.g., Veeva Vault), definition of workflows, user requirements, reporting capabilities, and configuration enhancements to support scalable execution and visibility.
- Provide strategic oversight of vendor-related quality risks and compliance issues, ensuring appropriate escalation, investigation, remediation, and continuous improvement activities.
- Support inspection readiness and regulatory inspections related to vendor oversight activities, ensuring vendor management processes and records are inspection-ready and aligned with global regulatory expectations.
- BS/MS degree in a scientific discipline.
- 10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years' experience overseeing Vendor Quality Management
- Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.
- Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.
- Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.
- Hands-on experience with systems such as Veeva Vault is preferred.
- Highly proactive, decisive, and capable of independently managing key initiatives.
About Scholar Rock
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Cambridge, MA, US
Year founded
2012