Validation Manager

Job Summary:Responsible for conducting regional audits/inspections on behalf of Astellas Pharma US, Inc. (APUS), focusing on computer software validation as is applicable to the collection, maintenance, and archiving of clinical research and commercial product and clinical research development data.Responsible for supporting the development, implementation and maintenance of the Validation Master Plan. Provides technical expertise in areas of computer software and hardware for tracking/trending, compliance activities and subsequent resolution of identified issues. Assures that applicable regional computer software/hardware systems and procedures comply with global/regional and regulatory standards.EOE(M/F/D/V)Job Responsibilities:1. Responsible for quality review of all validation documentation.2. Manages the preparation and maintenance of validation activities of documentation for inspection readiness.3. Implements and manages the Validation Review Board.4. Interfaces and maintains a working relationship with IS, Data Management, Research Data Sciences, APM, APT, and APCA regarding the development, implementation, and maintenance of compliant validated computer software application and hardware infrastructure.5. Communicates directly with Vendors/Contractors to resolve compliance, quality assurance, and quality control issues.6. Schedules and conducts audits of vendors/contractors for Part 11 compliance and applicable regional/global policies/standards to include regulatory requirements.7. Interfaces with management to identify major validation issues and prepares formal corrective action plans approved by respective senior management.8. Develops, implements, and manages the APUS Validation Program in accordance with 21 CFR Part 11 and applicable global/regional policies/standards.9. Provides training on Computer Software Validation and Electronic Record and Electronic Signature regulatory requirements.10. Interfaces with Product Complaints, CAPA, Change Control and Audit activities within the Trackwise system.11. Manages support activities surrounding the validation of Documentum and subsequent upgrade of the SOP system into Documentum.12. Manages internal e-business audits locally and within the region. Creates gap analyses and remediation plan based on outcome.13. Interfaces with QA management to assure cost effectiveness of systems and resources; assists with the management of routine activities.
REQUIREMENTS
Job Requirements: Bachelor’s degree or equivalent required. At least 7 years related experience; education in healthcare field in the area of compliance and quality assurance/quality control. Working knowledge of GxPs with emphasis on drug development; conduct of studies, computer software and hardware validation. Project management experience required; people management experience preferred.
Skills: Drug Development, Process Validation, Quality Control, Quality Management