Job Description

Title: Sr. IT Compliance Lead Consultant

Type of role: Contract or Perm
Location: Newark, CA

Our Biotech customer in the East Bay Area is seeking a dynamic and technically savvy individual to lead its IT Compliance function. This role primarily ensures that our customer’s new and existing GxP systems, including IT infrastructure, servers, process equipment and information systems remain compliant per current Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), FDA, ICH other regulatory requirements. This role is responsible for working with Quality to address Corrective and Preventive Actions (CAPAs), deviations, change controls, and execution of investigations and root cause analysis for instances of non-conformance. This position is also responsible for authoring standard operating procedures (SOPs) to ensure compliance with GxP requirements and actively work with Finance to ensure compliance with Sarbanes-Oxley 404 (SOX) requirements.

Essential Functions:
  • Coordinates the investigation, impact assessment and resolution for IT related quality events (e.g. CAPAs, deviations, change controls) validation and re-validation activities
  • Develop a strong partnership with Quality Assurance and other business partners to ensure the IT infrastructure and GxP systems are adhering to company policies and procedures
  • Collaborate with Quality Assurance to ensure timely resolution of CAPAs, deviations, change controls, and investigations and root cause analyses for instances of non-conformance
  • Plan, coordinate and review the validation, re-validation and qualification of IT infrastructure
  • Support the review and authoring of qualification/validation documentation for GxP systems
  • Author, review and implement IT infrastructure and system qualification related policies, procedures, work instructions while ensuring compliance with FDA and worldwide regulations
  • Provide general technical advice on changes to infrastructure, servers, process equipment, and information systems to ensure validation and qualification status is maintained and in a state of control
  • Maintain knowledge and expertise in compliance with various laws and regulations (GxP, 21CFR Part11, Eudralex Annex 11, GAMP5) and best practices
  • Address technical and compliance challenges in all phases of the System Validation Lifecycle; research, test, and generate solutions and mitigations
  • Partner with all levels of management, SOX PMO and internal /external auditors to ensure that SOX testing is conducted in a cooperative, timely and efficient manner
  • Identify on an on-going basis relevant industry trends and potential evolving risks facing IT initiatives, potential changes to IT internal controls over financial reporting and assess their impact
Required Skills:
  • Expertise in FDA, EMA, and ICH qualification / validation requirements and creative risk-based approaches for meeting and exceeding the minimum requirements
  • Experience developing, executing and reviewing validation protocols and deliverables
  • Ability to understand existing and new business processes and requirements to ensure proper qualification and validation of systems
  • Thorough understanding of key supporting quality systems including change control, deviation / non-conformance, and CAPAs
  • Excellent analytical and problem solving skills coupled with strong presentation skills
  • Excellent communication skills, both verbal and written
Preferred Experience:
  • Must have 7-10+ years managing GxP projects, particularly infrastructure qualification experience in biotechnology or pharmaceutical industry
  • Solid understanding of cloud infrastructure & virtual technologies (e.g. VMWare, Azure, etc.)
  • 5+ Years: Demonstrated leadership in computer system validation (CSV), IT Compliance and/or IT Quality Assurance
  • Thorough knowledge of GxP regulations related to CSV, including 21 CFR Part 11, Annex 11 and GAMP standards are required.
  • Root cause analysis and quality investigations; experience investigating and troubleshooting automation and control systems
Preferred Education:
  • BA/BS degree in Computer Science/Engineering/Science/Mathematics or related field

Application Instructions

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