Senior IT Quality Systems Leader - R&D & Compliance

Full-Time Sr. Manager, IT Quality Systems Location: San Francisco, California, United States Job Description The IT Senior Manager, R&D and Quality Systems is responsible for implementing and supporting R&D and quality business systems necessary for drug development in the cGMP environment. The position involves business analysis, planning, project management, implementation, computer systems validation, and ongoing support of business applications in Research & Development, Analytical, Regulatory Affairs, Clinical, Quality Affairs, and Quality Control. The role builds a team and managed service model for support of these business systems and is the primary interface between IT and the R&D and Quality business teams. This position reports to the Director, IT Business Services. Responsibilities Work with business users to improve existing processes, recommend automation and technology solutions. Assists implementation, administer methods and procedures to enhance operations based on industry best practices. Manage application support of R&D and Quality systems to ensure they meet business needs, user requirements, cGMP compliance, and GAMP5 guidelines. Ensure compliance with FDA regulations related to IT infrastructure, FDA 21 CFR Part 11 in applications, and SOX controls by all technical staff. Provide IT oversight for GXP computer systems validations per GAMP5 guidelines and apply risk‑based methodology to validation efforts. Follow processes and operational policies in selecting methods and techniques for obtaining solutions. Ensure budgets, user requirements, and schedules meet department expectations and business requirements or raise issues before criticality. Help develop resources and innovation to match the client’s continued growth in IT. Provide regular performance and development feedback to direct reports. Manage Service Level Agreements with customers and vendors. Requirements 8–12 years of experience; minimum 10+ years in system development, integration, and laboratory work within pharmaceutical or biotech industry. Minimum 5 years of previous management experience. Experience with laboratory automation systems and instrumentations in a pharmaceutical environment. Experience with R&D, Brand, Quality Assurance / Quality Control, Regulatory Affairs, Clinical, and Manufacturing environments regulated by the FDA. Experience with computer network validation. International experience with implementing quality systems. Experience with VMware in a regulatory environment. Bachelor’s degree in Computer Science, Information Systems, or related discipline (Master’s preferred). Experience with full system development life cycle, project management in large enterprise‑scale implementation projects, and laboratory automation applications. Solid knowledge of network and computing systems. Experience with Waters CDS, Trackwise, LIMS, Electronic Regulatory Filing System, Document Management, Quality Systems, Laboratory Operations. Experience with computer systems validation. Benefits Not specified. #J-18808-Ljbffr Blue Harbors Corporation