Job Details

Full-Time Sr. Manager, IT Quality Systems

Position Summary:

The IT Senior Manager, R&D and Quality Systems is responsible for implementing and supporting R&D and quality business systems required for drug development in the cGMP environment. This position is responsible for the business analysis, planning, project management, implementation, computer systems validation and ongoing support of business applications in the areas of Research & Development Analytical, Regulatory Affairs, Clinical, Quality Affairs and Quality Control. The position has the responsibility of building 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 to allow them to be automated and recommends business / technology solutions to various functional areas.
• Assists implementation, administer methods and procedures to enhance operations based on industry best practices.
• Manages the application support of R&D and Quality systems to ensure they meet business needs and user requirements, remains in compliance per cGMP requirements and GAMP5 guidelines.
• Ensure compliance with (1) FDA regulations related to IT infrastructure (2) Ensure compliance with FDA 21 CFR Part 11 in applications (3) Ensure compliance with 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.
• Ensures budgets, user requirements, and schedules meet department expectations and business requirements or escalate before situation is critical.
• Helps to develop resources and innovation to match the client's continued growth in IT.
• Responsible for providing regular performance and development feedback to direct reports.
• Manage Service Level Agreements with customers and vendors.

Requirements:

• 8-12 years of experience with a minimum of 10+ years of previous experience in system development, integration and laboratory work in the pharmaceutical or biotech industry is required.
• Requires a minimum of 5 years previous management experience.
• Experience with laboratory automation systems / instrumentations in a pharmaceutical environment.
• Experience with R&D, Brand, Quality Assurance / Quality Control, Regulatory Affairs, Clinical, 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 degree in Computer Science, Information Systems, or related discipline at a minimum. Master's Degree is preferred.
• Experience with full system development life cycle, project management in large system, enterprise scale, implementation projects and laboratory automation applications.
• Solid knowledge of network and computing systems is essential.
• Experience with Waters CDS, Trackwise, LIMS, Electronic Regulatory Filing System, Document Management, Quality Systems, Laboratory Operations.
• Experience with computer systems validation.