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Astellas is announcing a QA Validation/IT Manager position. Location, Northbrook, IL
Purpose & Scope of Position:
The QA Validation/IT Manager position is responsible for all aspects of Computer System Validation (CSV) for Astellas US Technologies (AUST) and QA Americas Region. Provides leadership and oversees the completion of computerized validation projects through the development and approval of validation schedules, project plans, validation plans, validation protocols and reports, and change control.
Essential Job Responsibilities:
• Responsible for operational management, planning, of the AUST Computer Validation program and QA validation initiatives. Develop validation test strategies and plans that provide adequate consideration of risk associated with business and technical drivers.
• Provides subject matter expertise (SME) on all aspects of the computerized systems lifecycle and validation principles and practices across all disciplines.
• Provide CSV oversight for all AUST computer validation projects to ensure that test deliverables are completed per internal / global guidelines and per Stakeholders expectations.
• Oversees AUST and QAA CSV projects to assure a quality output as well as compliance with global SDLC / CSV and applicable regulations.
• Manages the implementation of computer system change controls for Global Serialization Systems, SCM SAP, ADMS Technology, and others to track and monitor validation/revalidation activities.
• Collaborates closely with AUS IS Organization to insure compliance to internal/global procedures and applicable regulations.
• Provides leadership in driving a consistent computer system validation approach across the Astellas regions and provides support, technical guidance and advice to global teams in regards to SDLC/CSV requirements.
• Supports SDLC/CSV validation strategies and documentation collection during internal audit and third party inspections.
• Leads in developing validation strategies for complex and diverse decision-making that could have functional or global impact.
• Reviews and approves over hundred (100+) system development life cycle and computer system validation documents per year.
• Coordinate support staff of multiple external and internal team members.
• May lead direct reports and/or contractors and provide supervision and coaching to these individuals.
• BA / BS or equivalent, science-related preferred, with a minimum of 7 years of Pharmaceutical industry experience in computer system validation.
• In-depth knowledge of GxP regulations (e.g. Part 11 compliance) and computerized system validation in Pharmaceutical GxP regulated environment with a broad knowledge of quality principles and industry trends.
• Effective written / oral communication and interpersonal skills with an ability to effectively work across the Astellas group and with external/internal stakeholders to maintain effective relationships.
• Ability to apply industry knowledge and interpretation of regulations to anticipate global impact for CSV strategies to a variety of management levels.
• Ability to proactively predict and resolve complex problems, provide strategic and tactical thinking, and build consensus across a global organization.
• Working knowledge of validation requirements for Supply Chain SAP and Serialization Track and Trace System. Strong validation protocol writing skills.
• Experience in managing direct reports.
1. Strong planning and organizational skills and experience managing multiple priorities simultaneously.
2. Proficient in Microsoft Office.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled