Qa Software Testing Manager

Responsibilities

• Lead validation team in implementing tools and procedures to facilitate validation and documentation activities; and
• Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for business regulated software applications, including Validation & Test Plans, User Requirements & Functional Specifications, Functional & User Acceptance Testing, Traceability Matrices, and Validation Summary Reports;
• Ensure compliance of business computer systems with GxP and SOx regulatory requirements;
• Participate in Sponsor audits;
• Coordinate and assign systems and projects to validation staff according to priorities, timelines and availability;
• Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements;
• Maintain oversight of validation staff in managing change control of business software applications;
• Ensure consistency of systems validation SOPs with best practices of industry;

• Previous supervisory experience is preferred; and
• Bachelor's Degree;
• Knowledge and understanding of the application of Risk Management concepts;
• Excellent analytical, written, and oral communication skills;
• Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus!
• Advanced knowledge of software development life cycle;
• 7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry;