Director, Computer System Compliance

BeiGene•Hopewell, NJ

About The Position

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. General Description: 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 driving changes in the CSV/CSA domain by moving from static and paper-heavy compliance to dynamic and risk-based assurance with a specific focus on AI-driven platforms. 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.

Requirements

5+ years validation systems using Computer System Assurance methodologies including Agile and Waterfall approaches.
7+ years in software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation/ computer system assurance with at least 2 years focused on AI/ML or Advanced Analytics.
10+ years in Quality Assurance / Compliance including managing regulatory inspections for GxP, SOx system for multiple international regulatory bodies (e.g, MHRA, Health Canada, FDA, EMA).
Experience in at least one of the following manufacturing, facilities, process, laboratory method or cleaning validation.
Experience with managing enterprise demand and aligning 3rd party validation service providers.
Experience implementing Validation Management Tools and Automated testing tools.
Experience validating systems on AWS, Azure, or GCP (specifically SageMaker or Vertex AI and basic understanding of Python, R, or SQL to audit automated testing scripts and data pipelines.
Previous experience validating GxP systems not limited to Rockwell DCS, Empower CDS, Thermo Fisher LIMS, MODA for Environmental Monitoring, Biovia LES/ELN, Maximo CMMS, MES Systems.
Expert in GAMP 5 (including 2nd Edition), 21 CFR Part 11, and EudraLex Annex 11.
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.
Effective written and verbal communications skills.
Bachelor’s degree with minimum 10 years of relevant work experience in building, configuring, and validation of Manufacturing and Quality systems in a GxP regulated environment

Responsibilities

Serve as the GTS Lead for Computer Systems Validation/Computer System Assurance and Compliance across the company
Develop standards, set direction, build repeatable processes, adopt automation in CSV/CSA by establishing risk-based approaches for Generative AI (GenAI) and Large Language Models (LLMs) used in clinical or manufacturing settings
Leads execution of CSV/CSA deliverables for new and current Computerized Data Management systems.
Participates in the assessment and integration of new enterprise, industry, and regulatory guidance into site processes and systems including optimization & digitalization of the validation process.
Manage multiple computer system validation project resources including ensuring all resource expenditures are properly aligned to project budgets and within budget limits.
Provides input to the Software Development Lifecycle (SDLC) processes to represent regulated technologies including "Continuous Validation" loops to monitor model performance in production.
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 and functional Quality Organization to review, update and approve all GTS documentation to align with global standards.
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.
Support operations with troubleshooting and issue resolution on quality systems.
Lead small cross functional teams in support of small projects or initiatives.
Requires working in an industrial manufacturing environment including gowning.
Collaborate and work closely with Quality systems teams at other sites.