Quality Assurance Manager II

Job Description

Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across a single site. Confirm requests for quality support from the site and communicate policies and procedures. Proactive liaison with customer for quality assurance across site(s). Develop, manage, and oversee site quality resources. Support regional and sector QA and Regulatory Compliance initiatives, as required. Support validated processes as applicable for regulated hardware, equipment, and software systems. Oversee the maintenance and continuous improvement of the overall quality system or a specific procedure, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and developing and maintaining standard operating procedures/work instructions. Oversee regulatory licenses, permits, and registrations process. Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to cGxP, the contract (OSA, QAA/ TA), and customer requirements as applicable, reporting the results to executive management. Ensure that systems and equipment are validated (if applicable) and change control processes maintained. Lead key regulatory, customer and 3rd party audits. Monitor the training and development of site associates to ensure compliance to processes and regulations. Manage Quality Technicians within the site, as applicable.

Requirements

• Track and maintain quality assurance metrics for the organization.
• Track, monitor, and report quality assurance metrics for the site.
• Maintain and develop standard operating procedures/work instructions.
• Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to cGxP, the contract (OSA, QAA/ TA), and customer requirements as applicable, reporting the results to executive management.
• Oversee the maintenance and continuous improvement of the overall quality system or a specific procedure, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and developing and maintaining standard operating procedures/work instructions.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Oversee regulatory licenses, permits, and registrations process.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Oversee the maintenance and continuous improvement of the overall quality system or a specific procedure, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and developing and maintaining standard operating procedures/work instructions.
• Oversee regulatory licenses, permits, and registrations process.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory Compliance initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Support regional and sector QA and Regulatory