Area Quality Assurance Manager

Job Description

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). Proactively liaise with customers for quality assurance across sites. 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. Oversees the licenses, permits, and registrations process. Manages the validation process (as applicable) at a sector or network level and associated change control processes. Manages 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.

Works in coordination with the continuous improvement team to focus/direct continuous improvement activities/workshops. Reviews and provides recommendations on regulatory, customer and 3rd party audits. Identifies trends within the quality assurance metrics for the organization. Primary customer contact for QA related issues/initiatives as needed. Develops, distributes, and maintains regular management reports. Compiles executive level reports as required. Ensures site suppliers are assessed. Coordinates, prepares, receives, and acts on audits.

Required Education And Experience

• Bachelor's 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