Quality Assurance Manager

About the Role:

We are seeking an experienced, hands-on Quality Assurance (QA) Manager to lead quality assurance programs, regulatory compliance, and quality management systems (QMS) across multiple manufacturing facilities. This leadership position is responsible for maintaining consistent quality standards, overseeing manufacturing documentation, managing internal audits, implementing corrective and preventive actions (CAPA), and driving continuous improvement initiatives. The QA Manager will collaborate closely with Quality Control (QC), Manufacturing, Production, Compliance, and Research and Development (R&D) teams to ensure product quality, regulatory compliance, and operational excellence. The ideal candidate brings strong manufacturing quality assurance experience, technical expertise, and the ability to lead cross-functional quality initiatives in a fast-paced, multi-site manufacturing environment.

Responsibilities:

• Lead and manage quality assurance programs across multiple manufacturing facilities, ensuring consistent implementation of quality policies, procedures, documentation, and regulatory requirements.


• Develop, implement, maintain, and continuously improve quality management systems (QMS), standard operating procedures (SOPs), quality manuals, and manufacturing quality documentation.


• Oversee internal quality audits, compliance assessments, and manufacturing process evaluations to identify potential risks, nonconformances, and opportunities for operational improvement.


• Manage corrective and preventive action (CAPA) processes, including root cause analysis, quality investigations, corrective action implementation, and effectiveness verification.


• Partner closely with the Quality Control Manager to align quality assurance systems with daily product inspections, testing activities, manufacturing specifications, and established quality standards.


• Coordinate with Manufacturing, Production, Compliance, and R&D leadership to develop and execute quality improvement initiatives that enhance product consistency, reduce defects, and strengthen process reliability.


• Maintain regulatory compliance and audit readiness by ensuring accurate quality records, controlled documentation, traceability, and adherence to applicable industry standards.


• Support decisions regarding product holds, nonconforming materials, quality investigations, product disposition, and release authorization in accordance with established quality procedures.


• Monitor quality performance indicators (KPIs), audit findings, recurring nonconformances, and corrective action trends to identify systemic issues and recommend preventive improvements.


• Serve as the primary management contact for quality assurance matters across manufacturing locations, escalating significant quality concerns, regulatory risks, and unresolved compliance issues to executive leadership.

Qualifications:

• Bachelor's degree in Quality Management, Engineering, Manufacturing, Industrial Technology, Chemistry, or a related technical discipline, or equivalent relevant manufacturing quality experience.


• Minimum of 5 years of progressive experience in quality assurance, quality management, manufacturing compliance, or quality systems within a production or manufacturing environment.


• Demonstrated experience leading quality assurance operations, managing quality management systems (QMS), and maintaining consistent quality standards across manufacturing processes.


• Strong knowledge of quality assurance principles, quality control practices, regulatory compliance, standard operating procedures (SOPs), and controlled documentation systems.


• Hands-on experience conducting internal audits, managing nonconformances, performing root cause analysis, and implementing corrective and preventive actions (CAPA).


• Working knowledge of Good Manufacturing Practices (GMP), applicable manufacturing regulations, and recognized quality management standards.


• Experience collaborating with Quality Control, Manufacturing, Production, R&D, and Compliance teams to resolve product quality concerns and improve operational performance.


• Strong analytical, problem-solving, organizational, and documentation skills, with the ability to identify quality trends, investigate issues, and implement sustainable corrective actions.


• Demonstrated leadership and communication skills, including the ability to influence cross-functional teams, establish accountability, and communicate quality risks to senior management.


• Ability to work directly with manufacturing personnel, manage competing priorities, and support quality assurance activities across multiple manufacturing facilities.

Desired Qualifications:

• Experience managing quality assurance programs across multiple manufacturing locations, including standardizing quality systems, audit procedures, and compliance expectations.


• Familiarity with ISO 9001 quality management standards, internal auditor practices, regulatory inspections, and third-party certification processes.


• Professional certifications such as ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE).


• Experience applying Lean Manufacturing, Six Sigma, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), and other continuous improvement methodologies.


• Proficiency with electronic quality management systems (eQMS), enterprise resource planning (ERP) platforms, document control software, and quality reporting tools.


• Proven experience supporting product release decisions, supplier quality management, process validation, change control, and risk-based quality improvement initiatives.