Sr. Manager, CSV and IT Quality & Compliance

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The Senior Manager, Computerized System Validation (CSV) and IT Quality & Compliance is accountable for managing the IT Validation department and its activities for GXP applications / systems and maintain compliance. This is people manager role, responsible for managing Validation and Quality personnel and projects, and partners with Business and Technical Owners, MSAT and QA to manage the computerized systems’ lifecycles, including implementation, maintenance / change control and retirement of integrated electronic systems that improve the effectiveness, efficiency, and compliance across the Bothell and Dexter cell therapy GXP operations. This role also maintains the IT departments compliance and adherence to Quality standards and its delivery. This role reports to the Director, Site IT.

ROLES AND RESPONSIBILITIES:

• Lead development of the computerized systems validation strategy, including stage gate deliverables
• Plan and manage assigned CSV projects; manage author, review and/or approve processes for applicable CSV lifecycle documentation.
• Ensure the validation of computerized systems used across GXP operations is conducted in compliance with applicable regulatory requirements and internal procedures.
• Effectively partner with Business Owners, IT, and QA to ensure a compliant management of the computerized systems lifecycle.
• Act as subject matter expert for CSV and IT Quality during regulatory inspections
• Conduct impact assessments for changes impacting validated computerized systems.
• Maintain the inventory of all computerized systems and requalification / revalidation schedules.
• Oversee internal Validation employees and external their contractors, including training, assignment of projects and ensuring the timely completion of their deliverables.
• Track CSV deliverables and provide periodic progress reports to upper management and stakeholder

QUALIFICATION REQUIREMENTS

Education:

• Bachelor's degree in a life sciences, Technology or Engineering discipline (or equivalent industry experience)

Experience:

• 7+ years of direct experience with CSV activities, strong knowledge of GAMP, risk-based approach to validation and full understanding of electronic records and signatures
• 7+ years leading team of 5+ direct reports.
• Extensive knowledge of CSV-applicable regulations, current industry practices, and experience with interpretation and application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures.
• Expertise with development of CSV documentation (Assessments, Plans, Requirements, Specifications, Test Case Scenarios / Scripts, Reports, Trace Matrices, SOPs)
• Familiar with diverse computerized systems (i.e., ERP, MES, LIMS, PCS, Validation Lifecycle Software, QMS, Analytical Instrument controllers)
• Experience in developing CSV methodology for implementing and maintaining cloud-based technologies (i.e., Infrastructure [IaaS], Platform [PaaS] and Software [SaaS])

Working experience with Quality Management System (i.e., Deviation, CAPA, Change and Validation Lifecycle management systems)

Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining productivity and a positive work attitude

Licenses/Certifications:

WORKING CONDITIONS (US Only):

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsi