Director, Computer System Compliance

General Description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

This position will serve as the technical expert and lead for Computer System Validation/Computer System Assurance (CSV/CSA), Data Integrity & IT Compliance for IT Systems. The individual will be responsible for establishing processes, tools, and leading the execution of CSV/CSA for GTS. The individual will partner with cross‑functional teams and ensure the continuous improvement of IT services and maintain the integrity of electronic systems.

This position is responsible for performing periodic internal audits to ensure compliance with department procedures; assisting in department documentation generation, routing, review, and approval; assisting in qualification and qualification/validation activities; supporting GTS department engineers and administrators in operational support activities and performing other tasks of similar nature. This role works independently, with minimal supervision and direction, and will provide technical direction, project management support, commissioning, and SME expertise in the areas of Commissioning, Qualification, Validation, and Computer System Assurance.

• Serve as the GTS Lead for Computer Systems Validation/Computer System Assurance and Compliance
• Develop standards, set direction, build repeatable processes, adopt automation in CSV/CSA.
• Execute CSV/CSA deliverables for new and current Computerized Data Management systems.
• Participate in the assessment and integration of new enterprise, industry, and regulatory guidance into site processes and systems, including optimization & digitalization of the validation process.
• Be responsible for maintenance of the Computer System Lifecycle.
• Provide input to the Software Development Lifecycle (SDLC) processes to represent regulated technologies.
• Perform IT & Automation system risk assessments, periodic activities and oversee the process for completion according to quality procedures as required.
• Assist in performing impact and risk assessments and work with technical SMEs to close‑out GTS related Changes and Deviations/CAPAs as required.
• Provide technical expertise and leadership to define approaches and execution of system assurance & validation activities in accordance with cGxP, CFR 21 Parts 11, 210 and 211, Annex 11 and other applicable regulations or procedures.
• Represent GTS in site level change control meetings and act as main point of contact for change management, quality assurance and IS compliance as required.
• Work closely with Site Quality Organization to review, update and approve all GTS documentation to align with global standards.
• Be responsible for managing all aspects relating to internal and external audits of computerized systems.
• Represent GTS in network IT Quality, Security and Compliance forums by participating in security, compliance and risk management activities.
• Serve as the key GTS liaison for business continuity.
• Directly support operations with troubleshooting and issue resolution with respect to site quality systems.
• Lead small cross‑functional teams in support of small projects or initiatives.
• Require working in an industrial manufacturing environment including gowning.
• Collaborate and work closely with Quality systems teams at other sites.

• Strong experience with software lifecycle methodologies, 21
  
  CFR Part 11 compliance, and GxP computer systems validation/computer system assurance across all business domains.
• Previous experience in a GMP manufacturing, quality or operations environment validating GxP systems not limited to Rockwell DCS, Empower CDS, Thermo Fisher LIMS, MODA for Environmental Monitoring, Biovia LES/ELN, Maximo CMMS, MES Systems.
• Experience authoring and reviewing standard operating procedures, on‑the‑job trainings, and other controlled documents.
• Experience in managing small to medium‑sized projects and outside vendors.…