The Director, IT Software Quality Assurance is responsible for the strategy, planning and execution of the IT Quality Assurance function, including IT regulatory compliance and risk management, for ACM Global Laboratories.
STATUS: Full Time
LOCATION: ACM Global Laboratories
SCHEDULE: Monday – Friday
- Bachelor’s Degree required; degree focused in Computer Science, Software Engineering, Life Sciences or Business Administration preferred.
- 8 to 10 years of Quality & Compliance experience required; experience with hands-on computer system validation with CTMS/LIS/LMIS preferred.
- Knowledge in FDA regulations, cGxP, cGMP, cGAMP, cGLP, Systems Development Lifecycle (SDLC), Change Control, SOP Development, SQA Methodologies, etc.
- Leadership. Provide leadership and vision to a team of IT Quality Assurance professionals who support global IT regulatory compliance. Hire, train and develop IT Quality Assurance team. Strategically partner with Quality Assurance & Regulatory Affairs, RRH Information Technology and ACM Project teams.
- Information Technology. Expert IT knowledge system testing, user acceptance testing, traceability matrices, design specs, validation deliverables (requirements, compliance/validation, protocols, validation summary reports and compliance/validation reports), SQA Methodologies, SDLC, and SOPs.
- Quality Assurance. Support internal and external compliance audits, including those with commercial clients and regulatory bodies. Maintain expert knowledge of compliance & regulations associated with IT Quality Assurance. Manage all SOPs, policies, training records, validation protocols and controlled documents. Develop and maintain KPIs aligned to organizational goals.
- Project Management. Assist and manage all phases of Project Management. Work closely with all areas to ensure IT Quality Assurance is incorporated into the system lifecycle.
EDUCATION BS (Required) LICENSES/CERTIFICATIONS NYS DL - valid New York State Driver's License - New York State Department of Motor Vehicles (NYSDMV)
Job ID REQ_88203