O pracy
Responsible for overseeing the overall Quality function of the Fagron Services North America Minneapolis organization. Creates, implements, prioritizes, and communicates the facilities’ Quality strategy and its Quality programs, aligning with Fagron Corporate Quality Strategy & Programs. Promotes recognition of Quality programs throughout the organization. Responsible for translating the company’s Quality strategy into tactical policies, processes, and procedures to meet overall regulatory requirements and cGMP.
Essential Job Functions
Leads the development and maintenance of facility Quality Management System and associated procedures and authorizes the implementation of these, ensuring alignment to Fagron company policies. Provides general direction to and review of the Quality function within the organization.
Responsible for site audit readiness and ensures adoption and compliance to all applicable regulatory (FDA, DEA, State) standard requirements, guidance and best practices applicable to the site and its products.
Leading all external regulatory inspections of the Fagron Services North America Minneapolis business, coordinating own and peer departments in preparation and support of such assessments.
Directs all Quality related activities within the organization through functional managers in Quality Assurance and Quality Control.
Full Quality Operational oversight and responsibility for the analytical and microbiological laboratory operation.
Identifies and implements creative solutions to abstract problems across the Quality function of the organization. Identifies and evaluates fundamental issues and potential areas of improvement.
Actively supports senior leadership in the development and formulation of long and short-range planning, policies, programs and objectives. Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people. Responsible for product quality oversight, management and escalation from a Quality perspective, to senior leadership.
Ensures own and business awareness of regulatory guidelines and guidance documents; including current Good Manufacturing Practices and new technology affecting the Quality function to ensure compliance with regulatory and corporate quality policies, and the goals of the company.
Develop, execute and maintain site Quality KPI Dashboard, ensuring performance levels attained deliver on expected target goals and demonstrate best in class performance.
Partner with Research and Development, Global Quality, Customer Service, and Manufacturing departments to ensure coordination, integration, and execution of Quality activities across all departments.
Perform Quality related activities periodically as necessitated.
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Job Requirements
Bachelors degree in scientific discipline required. Masters or PhD degree in related field preferred.
Minimum of 10 years relevant quality systems experience in a pharmaceutical, biotechnology, or food manufacturing environment.
Strong Change management experience with a demonstrated track record of continuous improvement
Significant professional experience with LIMS, ERP, and EQMS systems is preferred.
Proven track record in staff and organization development – coaching, counseling and team building. Supervisory experience required.
Experience building, designing, and leading an organization’s quality systems within a dynamic, growing, fast paced environment.
Must possess excellent project management and organizational skills.
Excellent interpersonal, verbal, and written communication skills, with the ability to clearly and effectively present complex and technical materials to internal and external audiences.
Proven ability to effectively communicate and interact with individuals throughout all levels of an organization; including, executive level management.
Oferujemy
Fagron US offers its associates competitive compensation and a wide range of benefits including a 401(k) plan with a generous company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.