Senior Manager, IS Quality and Compliance

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Requirements:

• Minimum bachelor's degree in science or IT-related discipline.
• Minimum 10 years of professional and management experience in a GxP regulated environment.
• Minimum 10 years of Computer System Validation experience in the pharmaceutical/biopharma sector.
• Working knowledge of GxP regulations, CSV/CSA principles, and relevant compliance standards.
• Awareness of FDA Computer Software Assurance principles.
• Ability to lead multiple CSV projects for complex systems.
• Understanding of CSV for cloud-based/SaaS systems.
• Experience performing third-party vendor audits, focusing on security and privacy.
• Knowledge of IT security frameworks such as NIST, ISO/IEC 27001, SOC 2.
• Familiarity with regulations like GDPR, HIPAA, and Sarbanes-Oxley.

Responsibilities:

• Provide project and CSV leadership for GxP computerized systems.
• Collaborate with IS, vendors, System/Business Owners, and Quality.
• Oversee the CSV program, including creating and approving validation documentation.
• Own CSV-related incidents and manage remediation efforts.
• Perform inspection readiness preparations and support regulatory audits.
• Manage change control activities for GxP systems.
• Communicate identified gaps and recommend corrective actions.
• Serve as IS subject matter expert on Data Integrity and CSV lifecycle.
• Partner with others to complete vendor assessments and security evaluations.