Quality Assurance Manager II

QA Manager II

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. Hire, train, and develop QA Supervisor, QA Specialist, QA Tech I, QA Tech II roles. Track and maintain quality assurance metrics for the organization. Act as primary customer contact for QA related issues / initiatives as needed. Track, monitor, and report quality assurance metrics for the site. Develop, distribute and maintain regular management reports. Lead and support cross functional continuous improvement projects / continuous improvement activities / workshops. Ensure customer service and business standards requirements are met daily. Plan, conduct, and act upon inspection processes- Gemba; Standards Confirmation etc on a daily basis.

Required Education and Experience : Bachelor Degree or equivalent 4 years work experience, required. Certification related to quality control, preferred. 3+ years experience in a regulated environment OR ISO 9001 compliant or certified, required. 1+ years of supervisory or management experience, required. Manufacturing, Food, Life Sciences, or 3PL Industry experience, required. Participation in successful standards organization registration in a complex environment. Supervising or implementing quality control programs. Knowledge of regulations such as FDA, GxPs, ATF, DEA, etc. Administrator of training in compliance to regulated standards. 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.