Lead quality operations ensuring compliance with GMP standards and drive continuous improvement in a regulated manufacturing environment.
Position Overview:
We are seeking a highly experienced Manufacturing Quality Manager with extensive Good Manufacturing Practices (GMP) expertise to lead our quality operations within a regulated manufacturing environment. This role is responsible for ensuring that all products are manufactured in compliance with GMP standards, regulatory requirements, and internal quality systems. The ideal candidate will have a strong background in managing quality assurance and quality control teams, implementing continuous improvement initiatives, and supporting regulatory audits.
Responsibilities:
Oversee all aspects of quality management systems (QMS) within the manufacturing environment.
Ensure compliance with GMP regulations, ISO standards, and company quality policies.
Develop, implement, and maintain quality procedures, policies, and documentation.
Lead internal and external audits, including FDA, ISO, and customer audits.
Manage CAPA (Corrective and Preventive Action) and deviation systems to ensure timely resolution and preventive actions.
Review and approve manufacturing batch records, validation protocols, and change control documentation.
Partner with production, engineering, and supply chain teams to identify quality risks and drive continuous improvement.
Provide quality oversight of suppliers, contractors, and raw materials.
Lead root cause analysis and implement long-term quality improvement strategies.
Train and mentor quality staff on GMP and compliance requirements.
Latitude Inc. is a Human Resource Consulting Firm providing staffing solutions and government services for companies and the public sector. They offer industry-specific consulting, contract, contract-to-hire, and permanent placement services across IT,...
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