Area Quality Assurance Manager

Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across multiple sites. Confirm requests for quality support from the site and communicate policies and procedures. Expert regarding selected governmental regulations for the site(s). Proactive liaison with customer for quality assurance across site(s). Leads a defined group of Quality Assurance resources and key initiatives, disseminating regulatory and corporate policy changes. Develops and implements policy and procedures for sites under their responsibility. Develop, manage, and oversee site quality managers/coordinators. Leads global and cross-sector QA initiatives. Develops and implements processes for regulated hardware, equipment, and software systems (validated as applicable).

• Oversee the maintenance and continuous improvement of the overall quality system for multiple sites or multiple customers within a site, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions
• Oversee the licenses, permits, and registrations process
• Manages the validation process (as applicable) at a sector or network level and associated change control processes
• Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to regulatory guidelines, the contract, and customer requirements; reporting the results to executive management
• Work in coordination with continuous improvement team to focus/direct continuous improvement activities/workshops
• Review and provide recommendations on regulatory, customer and 3rd party audits
• Review and identify trends within the quality assurance metrics for the organization
• Primary customer contact for QA related issues/initiatives as needed
• Develop, distribute and maintain regular management reports. Compile executive level reports as required
• Ensure site suppliers are assessed. Coordinate, prepare, receive, and act on audits

Required Education And Experience

• Bachelors Degree or equivalent 4 years work experience, required
• 7+ years of relevant experience in a regulated environment, required
• 5+ years of supervisory or management experience, required
• Certification related to quality control (RAC, Six-Sigma, etc.), preferred
• People management
• Sufficient computer application experience
• Strong written and verbal communication
• Data analysis experience
• Training and facilitation skills
• Self management
• Problem solving
• Project management
• Presenting
• Report creation
• Solution execution
• Process development
• People development
• Quality program start-up experience
• Standards development
• Customer management

Our Organization is an equal opportunity employer.