Director of Quality
Conf, Winthrop, MA, United States
A rapidly scaling specialty manufacturing organization is seeking a
Director of Quality
to lead all Quality functions. This executive leader will own quality strategy, regulatory compliance, inspection readiness, and QMS excellence across development, commercial manufacturing, and chemical production environments. This is a high-impact, succession-path role reporting directly into executive leadership. The role is located 30 minutes north of Boston. Key Responsibilities Quality Systems Leadership:
Lead the enterprise Quality Management System (QMS), ensuring compliance, documentation discipline, and scalable systems that support specialty chemical manufacturing. Regulatory Compliance & Inspection Readiness:
Oversee all compliance and audit-readiness efforts, guiding teams through regulatory expectations, customer audits, and continuous inspection preparedness. Root Cause Analysis & CAPA Oversight:
Direct investigations, root cause analysis, and CAPA programs to ensure effective, sustainable corrective actions across all sites. Quality Metrics & Executive Reporting:
Define and communicate enterprise quality KPIs, delivering insights and risk assessments to senior leadership. Supplier Quality Management:
Lead supplier qualification and auditing programs, ensuring raw material and component suppliers meet stringent capability and purity requirements. Change Control Governance:
Oversee the global change control process with strong risk evaluation, cross-functional alignment, and disciplined documentation. Culture, Training & Continuous Improvement:
Strengthen quality culture through training, coaching, and deployment of Lean/CI tools and standard work. Product Release & Material Review:
Provide final disposition on in-process and finished materials; lead MRB activities to ensure compliant, data-driven release decisions. Qualifications Bachelors degree required; advanced education or professional certifications (e.g., CQE, CQM) preferred. 10+ years of leadership experience in Quality within highly regulated manufacturing (pharmaceutical, specialty chemical, CDMO, or similar). Experience with cGMP (21 CFR 211), ISO 9001/13485, and applicable ICH quality guidelines. Strong knowledge of quality systems, compliance frameworks, and regulatory expectations for controlled production environments. Proven success leading, developing, and scaling high-performing Quality teams in fast-paced, multi-site operations. Experience with digital QMS platforms and data-driven quality tools. EOE
Director of Quality
to lead all Quality functions. This executive leader will own quality strategy, regulatory compliance, inspection readiness, and QMS excellence across development, commercial manufacturing, and chemical production environments. This is a high-impact, succession-path role reporting directly into executive leadership. The role is located 30 minutes north of Boston. Key Responsibilities Quality Systems Leadership:
Lead the enterprise Quality Management System (QMS), ensuring compliance, documentation discipline, and scalable systems that support specialty chemical manufacturing. Regulatory Compliance & Inspection Readiness:
Oversee all compliance and audit-readiness efforts, guiding teams through regulatory expectations, customer audits, and continuous inspection preparedness. Root Cause Analysis & CAPA Oversight:
Direct investigations, root cause analysis, and CAPA programs to ensure effective, sustainable corrective actions across all sites. Quality Metrics & Executive Reporting:
Define and communicate enterprise quality KPIs, delivering insights and risk assessments to senior leadership. Supplier Quality Management:
Lead supplier qualification and auditing programs, ensuring raw material and component suppliers meet stringent capability and purity requirements. Change Control Governance:
Oversee the global change control process with strong risk evaluation, cross-functional alignment, and disciplined documentation. Culture, Training & Continuous Improvement:
Strengthen quality culture through training, coaching, and deployment of Lean/CI tools and standard work. Product Release & Material Review:
Provide final disposition on in-process and finished materials; lead MRB activities to ensure compliant, data-driven release decisions. Qualifications Bachelors degree required; advanced education or professional certifications (e.g., CQE, CQM) preferred. 10+ years of leadership experience in Quality within highly regulated manufacturing (pharmaceutical, specialty chemical, CDMO, or similar). Experience with cGMP (21 CFR 211), ISO 9001/13485, and applicable ICH quality guidelines. Strong knowledge of quality systems, compliance frameworks, and regulatory expectations for controlled production environments. Proven success leading, developing, and scaling high-performing Quality teams in fast-paced, multi-site operations. Experience with digital QMS platforms and data-driven quality tools. EOE