Position Summary:

The Senior Manager, IT Assurance and Compliance is responsible for ensuring all GxP Laboratory and Manufacturing instrument and equipment software and computerized systems are implemented, validated, and maintained in compliance with applicable regulatory and industry standards, including FDA, including FDA, ICH, GAMP 5, and global Health Authority requirements. This role leads validation efforts for new and existing software implementations, manages the lifecycle of validated systems, and ensures sustained compliance through continuous monitoring and governance. This role combines deep technical expertise in computer system validation, a strong understanding of quality systems, and excellent cross-functional collaboration skills to ensure IT systems operate reliably, securely, and compliantly across the enterprise.

Essential Duties & Responsibilities:

• Lead validation projects, including the planning, execution, and documentation of computer system validation deliverables.
• Lead qualification, validation, and periodic review activities for laboratory and manufacturing instrument software and systems
• Ensure continued GxP compliance of QC laboratory computer systems and software.
• Coordinate with IT Operations team to ensure data backup and disaster recovery strategies for critical laboratory systems are setup.
• Collaborate with QA teams to ensure alignment of priorities and delivery of outcomes (policies, procedures and documents).
• Provide guidance and oversight to ensure computerized systems are deployed and maintained following the full system lifecycle (SDLC), IT change control, and applicable SOPs.
• Review and approve validation deliverables authored by internal teams and external vendors.
• Manage multiple validation and compliance projects simultaneously, balancing priorities across manufacturing, clinical, and corporate systems.
• Ensure audit and inspection readiness by maintaining documentation quality, traceability, and regulatory alignment.
• Lead the creation, revision, and implementation of IT governance SOPs and quality documentation, ensuring alignment with FDA Computer Software Assurance (CSA) principles and risk-based validation strategies.
• Conduct audits of IT systems, vendors, and validation documentation.
• Partner with QA and business stakeholders to maintain validated system compliance through release management, change control, incident management, CAPA, periodic reviews, and audit trail reviews.
• Conduct impact and risk assessments for changes affecting validated systems and ensure appropriate mitigation actions.
• Maintain the inventory of all GxP computerized systems, ensuring re-qualification/revalidation schedules are current and properly documented.
• Perform system risk assessments to determine GxP classification and validation requirements.
• Manage vendor qualification activities, including the distribution and evaluation of IT vendor questionnaires and supporting audits or assessments.
• Be onsite to provide vendor oversight, when needed.

Qualifications:

• Education/Training:
  • Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related technical or scientific discipline required.
• Experience:
  • 8+ years of experience in computer system validation (CSV), IT quality, or IT compliance roles within a regulated environment.
  • Strong background in validation of systems such as, LIMS, MES, and other Laboratory/Manufacturing systems.
  • Experience supporting both Manufacturing and Clinical Study Systems required.
• Knowledge:
  • In-depth understanding of global CSV guidelines and regulatory expectations, including 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices (GCP), and Data Integrity principles.
  • Familiarity with FDA Computer Software Assurance (CSA) guidance and risk-based validation methodologies.
  • Strong working knowledge of cloud-based and SaaS system validation approaches.
• Skills:
  • Excellent organizational, analytical, and problem-solving skills with the ability to manage multiple priorities.
  • Strong written and verbal communication skills, with proven ability to work effectively across departments.
  • High attention to detail and commitment to quality and compliance.
  • Ability to foster collaboration between IT, Quality, and business functions.
• Certifications/Licenses:
• Preferred: Certification in quality or regulatory compliance.