DBV Technologies
Director - Quality Management Systems
DBV Technologies - Trenton, New Jersey, United States
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Director - Quality Management Systems
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Director - Quality Management Systems
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DBV Technologies Get AI-powered advice on this job and more exclusive features. The Senior Manager, Quality Assurance supports the Quality function and ensures the strategic plans and objectives set forth by the Senior Director, QMS are met. The primary function of this role will be to lead the development , implementation, and maintenance of the document management, quality event management, and learning management elements of the quality management system across the organization to ensure compliance with medical device and pharmaceutical/biologics QMS requirements. This role requires strong leadership and expertise in quality management system principles, regulatory requirements, and industry best practices. Location: Warren, NJ Hybrid - on site 3 days a week KEY DUTIES & RESPONSIBILITIES Document Management Own the DBV Global Quality Document Management System including the hierarchy, Quality Manual, and document storage and archiving processes and systems . Identify and lead the expansion of current systems to ensure DBV compliance across all GxP functional areas. Administer the Document Periodic Review process. Quality Event Management Lead the continued development and maintenance of the quality event management (deviations, changes, CAPAs, etc.) processes and associated software tool(s). Ensure these processes are effectively managed and training provided throughout DBV
The Senior Manager, Quality Assurance supports the Quality function and ensures the strategic plans and objectives set forth by the Senior Director, QMS are met. The primary function of this role will be to lead the development , implementation, and maintenance of the document management, quality event management, and learning management elements of the quality management system across the organization to ensure compliance with medical device and pharmaceutical/biologics QMS requirements. This role requires strong leadership and expertise in quality management system principles, regulatory requirements, and industry best practices. Location: Warren, NJ Hybrid - on site 3 days a week KEY DUTIES & RESPONSIBILITIES Document Management Own the DBV Global Quality Document Management System including the hierarchy, Quality Manual, and document storage and archiving processes and systems . Identify and lead the expansion of current systems to ensure DBV compliance across all GxP functional areas. Administer the Document Periodic Review process. Quality Event Management Lead the continued development and maintenance of the quality event management (deviations, changes, CAPAs, etc.) processes and associated software tool(s). Ensure these processes are effectively managed and training provided throughout DBV
Learning Management
Lead the development and maintenance of the global GxP training program for initial and on-going training needs of DBV staff and contractors, as required Design and maintain a comprehensive and effective GxP training program covering GMP, GCP, GLP, and other relevant regulatory requirements. Ensure training materials are current with evolving regulatory standards and internal policies. Support training matrix management. QMS Metrics Develop and track key quality metrics. Provide regular reports and updates to senior management regarding QMS performance, trends, and continuous improvement efforts. Inspection Readiness Participate and provide leadership supporting the global inspection readiness and management program for hosting and managing regulatory authority inspections arising during drug development and commercial operations. This includes on-site audits by health authorities or other regulatory entities, as well as off-site inspections at our CROs, CDMOs, and testing facilities supporting DBV development programs Lead development of responses to agency observations or deficiencies and ensure CAPAs are completed timely with appropriate effectiveness verification. Leadership & Management Participate in the development and presentation of the Quality Management Review program to identify and communicate significant quality systems or product issues to executive management and make recommendations for continuous process improvements and the promotion of best practices utilizing Key Performance Indicators as appropriate. Lead and manage junior members of the QMS team, providing direction, mentoring, and development opportunities. Collaborate with cross-functional teams to integrate quality standards throughout the QMS and to foster a culture of continuous improvement and regulatory compliance. Travel This position will require approximately 20% travel to France. QUALIFICATIONS Bachelor’s degree in a relevant field (e.g., engineering, life sciences, quality management) with an advanced degree preferred. Regulatory and/or Quality Assurance certifications are a plus. Minimum of 10 -12 years of increasing responsibility in a biotechnology/pharmaceutical, GxP-related Quality & Compliance environment. Combination product, medical device and/or biologics experience is preferred. Minimum 7 - 10 years direct and indirect management level experience including senior level project planning and working/managing in a global environment. Extensive and demonstrated experience of developing and managing a global QMS within a global biotechnology company Experience within 1 or more eQMS platforms for 5+ years (Veeva/ComplianceWire desired). Extensive knowledge, understanding, and practical implementation of FDA, ICH, and other GXP requirements to develop, maintain, and expand a comprehensive QMS program at a biotechnology company. Experience in QMS implementation in a Biologics and/or Combination Product (preferred) environment. Experience and practical expertise in developing and implementing Quality Management Systems and Governance meeting the requirements of FDA 21 CFR 211/820, ICH Q8, 9, and 10, and ISO 13485; 21 CFR part 600 desired Strong written and verbal communication skills, analytical problem solving, and conflict resolutions skills to manage and support a cross-functional Team and global organization. Flexible, highly motivated, with strong organization skills and the ability to multitask. Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic environment. This is a senior level position that also requires a hands-on, direct management and ownership approach with the QMS Team. This is not a strategic and/or management alone position. Ability to work independently and to make decisions based on experience. Effective interpersonal skills. Fluent in English reading, writing, and speaking is a must; fluency in French is a plus. Behavioral Skills Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”, Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions, Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals, Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology. The typical compensation range for this role is $155,000 - $170,000 per annum depending on experience, plus full benefits including but not limited to: annual bonus, 15 vacation days, health, dental and optical insurance, plus much more! Seniority level
Seniority level Not Applicable Employment type
Employment type Other Job function
Job function Quality Assurance Referrals increase your chances of interviewing at DBV Technologies by 2x Sign in to set job alerts for “Director Quality Management” roles.
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Director - Quality Management Systems
role at
DBV Technologies 16 hours ago Be among the first 25 applicants Join to apply for the
Director - Quality Management Systems
role at
DBV Technologies Get AI-powered advice on this job and more exclusive features. The Senior Manager, Quality Assurance supports the Quality function and ensures the strategic plans and objectives set forth by the Senior Director, QMS are met. The primary function of this role will be to lead the development , implementation, and maintenance of the document management, quality event management, and learning management elements of the quality management system across the organization to ensure compliance with medical device and pharmaceutical/biologics QMS requirements. This role requires strong leadership and expertise in quality management system principles, regulatory requirements, and industry best practices. Location: Warren, NJ Hybrid - on site 3 days a week KEY DUTIES & RESPONSIBILITIES Document Management Own the DBV Global Quality Document Management System including the hierarchy, Quality Manual, and document storage and archiving processes and systems . Identify and lead the expansion of current systems to ensure DBV compliance across all GxP functional areas. Administer the Document Periodic Review process. Quality Event Management Lead the continued development and maintenance of the quality event management (deviations, changes, CAPAs, etc.) processes and associated software tool(s). Ensure these processes are effectively managed and training provided throughout DBV
The Senior Manager, Quality Assurance supports the Quality function and ensures the strategic plans and objectives set forth by the Senior Director, QMS are met. The primary function of this role will be to lead the development , implementation, and maintenance of the document management, quality event management, and learning management elements of the quality management system across the organization to ensure compliance with medical device and pharmaceutical/biologics QMS requirements. This role requires strong leadership and expertise in quality management system principles, regulatory requirements, and industry best practices. Location: Warren, NJ Hybrid - on site 3 days a week KEY DUTIES & RESPONSIBILITIES Document Management Own the DBV Global Quality Document Management System including the hierarchy, Quality Manual, and document storage and archiving processes and systems . Identify and lead the expansion of current systems to ensure DBV compliance across all GxP functional areas. Administer the Document Periodic Review process. Quality Event Management Lead the continued development and maintenance of the quality event management (deviations, changes, CAPAs, etc.) processes and associated software tool(s). Ensure these processes are effectively managed and training provided throughout DBV
Learning Management
Lead the development and maintenance of the global GxP training program for initial and on-going training needs of DBV staff and contractors, as required Design and maintain a comprehensive and effective GxP training program covering GMP, GCP, GLP, and other relevant regulatory requirements. Ensure training materials are current with evolving regulatory standards and internal policies. Support training matrix management. QMS Metrics Develop and track key quality metrics. Provide regular reports and updates to senior management regarding QMS performance, trends, and continuous improvement efforts. Inspection Readiness Participate and provide leadership supporting the global inspection readiness and management program for hosting and managing regulatory authority inspections arising during drug development and commercial operations. This includes on-site audits by health authorities or other regulatory entities, as well as off-site inspections at our CROs, CDMOs, and testing facilities supporting DBV development programs Lead development of responses to agency observations or deficiencies and ensure CAPAs are completed timely with appropriate effectiveness verification. Leadership & Management Participate in the development and presentation of the Quality Management Review program to identify and communicate significant quality systems or product issues to executive management and make recommendations for continuous process improvements and the promotion of best practices utilizing Key Performance Indicators as appropriate. Lead and manage junior members of the QMS team, providing direction, mentoring, and development opportunities. Collaborate with cross-functional teams to integrate quality standards throughout the QMS and to foster a culture of continuous improvement and regulatory compliance. Travel This position will require approximately 20% travel to France. QUALIFICATIONS Bachelor’s degree in a relevant field (e.g., engineering, life sciences, quality management) with an advanced degree preferred. Regulatory and/or Quality Assurance certifications are a plus. Minimum of 10 -12 years of increasing responsibility in a biotechnology/pharmaceutical, GxP-related Quality & Compliance environment. Combination product, medical device and/or biologics experience is preferred. Minimum 7 - 10 years direct and indirect management level experience including senior level project planning and working/managing in a global environment. Extensive and demonstrated experience of developing and managing a global QMS within a global biotechnology company Experience within 1 or more eQMS platforms for 5+ years (Veeva/ComplianceWire desired). Extensive knowledge, understanding, and practical implementation of FDA, ICH, and other GXP requirements to develop, maintain, and expand a comprehensive QMS program at a biotechnology company. Experience in QMS implementation in a Biologics and/or Combination Product (preferred) environment. Experience and practical expertise in developing and implementing Quality Management Systems and Governance meeting the requirements of FDA 21 CFR 211/820, ICH Q8, 9, and 10, and ISO 13485; 21 CFR part 600 desired Strong written and verbal communication skills, analytical problem solving, and conflict resolutions skills to manage and support a cross-functional Team and global organization. Flexible, highly motivated, with strong organization skills and the ability to multitask. Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic environment. This is a senior level position that also requires a hands-on, direct management and ownership approach with the QMS Team. This is not a strategic and/or management alone position. Ability to work independently and to make decisions based on experience. Effective interpersonal skills. Fluent in English reading, writing, and speaking is a must; fluency in French is a plus. Behavioral Skills Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”, Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions, Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals, Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology. The typical compensation range for this role is $155,000 - $170,000 per annum depending on experience, plus full benefits including but not limited to: annual bonus, 15 vacation days, health, dental and optical insurance, plus much more! Seniority level
Seniority level Not Applicable Employment type
Employment type Other Job function
Job function Quality Assurance Referrals increase your chances of interviewing at DBV Technologies by 2x Sign in to set job alerts for “Director Quality Management” roles.
Cranbury, NJ $150,000.00-$180,000.00 1 week ago Warren, NJ $185,000.00-$215,000.00 4 weeks ago Executive Director/VP Quality and Regulatory
New Brunswick, NJ $120,000.00-$170,000.00 4 days ago Associate Director, Quality Assurance - Third Party Quality Management - Hybrid
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