Quality Systems Manager – HudsonAlpha Institute for Biotechnology – Huntsville, AL, USA
iCubate® is seeking a Quality Systems Manager to develop, implement and maintain a quality system in accordance with FDA Quality System Regulations, GMP guidelines and ISO 13485 requirements. Additionally, the Quality Systems Manager will guide multiple products through a FDA 510(k) process.
Position Summary:
Manage Quality Control team, laboratory and analytical quality control testing. Maintain a controlled environment through an environmental monitoring plan, personnel controls and exceptional laboratory material.
Develop and lead a broad set of FDA Quality Compliance, Release and Systems activities for the successful production and release of in-vitro diagnostic products.
Manage Non Conformance Reports and all Corrective and Preventative Actions (CAPA).
Work with Regulatory Consultants to prepare 510K submission
Oversee implementation of Quality System and the development of new SOP’s, FORMs, Test Procedures and Work Procedures.
Manage changing conditions, processes and approaches; lead organizations through change effectively.
Strong understanding of Supplier Quality, Cold Chain Management, Logistics and Distribution, Design Control, Risk Analysis, and Statistical Process Control.
Critical Competencies:
Ability to move others to action, including peers, superiors and subordinates.
Ability to demonstrate a positive, results-oriented style.
Ability to develop others, and manage performance of team
Ability t o present complex information to internal and external audiences
Ability to express abstract and controversial ideas clearly and effectively; ensure communications, key decisions and strategies are understood in all settings.
Ability to use an analytical approach and evaluate a situation from varying perspectives to create well-reasoned solutions.
Ability to foster excellent relationships and credibility quickly at all levels of the organization.
Ability to collaborate across the company (internal and consultants) at all levels, across functional groups
Ability to provide a good balance of risk taking and sound judgment in order to deliver optimal results.
Ability to drive goal attainment in others with energy and focus.
Ability to organize and maintain quality and regulatory documentation.
Education and Required Skills Experience:
Bachelors of Science in biochemistry, molecular biology, microbiology, chemistry or genetics.
2+ years medical device product development
2+ years working in FDA-regulated Quality Environment
2+ years managing a team in a clinical environment
Working knowledge of ISO 13485 and FDA 21 CFR 820 Quality System Regulation
Experience in molecular biology or molecular diagnostics a plus.
QC method design, optimization and validation experience required.
2+ years writing protocols, SOPs, etc.
Benefits:
iCubate ® offers excellent employee benefits including an employer matching retirement plan and insurance package (including medical, vision, and dental). Additionally, iCubate ® offers company paid short and long-term disability and life insurance.
